EMA兽药司发布兽药集中审批及变更等各类申请推荐提交日期表
Recommended submission dates for veterinary medicinal products
EMA兽药司发布兽药各类申请的推荐提交日期表，涵盖集中审批初始申请（120天评估）、MRL申请、问答清单回复、变更评估及VAMF/vPTMF等17类程序。表格列出2025年至2028年各轮次的提交截止日、验证完成日及CVMP采纳问答清单日期。EMA强烈建议在公布截止日前最多7天提交申请。
PDF 文字版；图形和原始排版请参阅官方 PDF。
第 1 页
Veterinary Medicines Division
Recommended submission dates
Table of Contents
1. Centralised (initial applications) – 1st phase (120-day assessment) ........................ 2
2. MRL applications – 1st phase (120-day assessment) ............................................. 4
3. Responses to the list of questions (LoQ) – 2nd phase (60-day assessment after clock-
stop for responses) ........................................................................................... 6
4. Responses to the list of outstanding issues – 3rd phase (30-day assessment after
clock-stop for outstanding issues or after oral explanation) .................................... 8
5. Responses to the list of questions (LoQ) further to the establishment of provisional
MRLs (90-day assessment after clock-stop for responses) ....................................10
6. Informed consent – 1st phase (60-day assessment) ............................................12
7. Variations requiring assessment (extended timetable) – 1st phase ........................14
8. Variations requiring assessment (standard timetable) – 1st phase .........................16
9. Variations requiring assessment (reduced timetable – weekly submissions) – 1st
phase.............................................................................................................18
10. Variations requiring assessment (reduced timetable with linguistic review – monthly
submissions) – 1st phase .................................................................................26
11. Response to the request for supplementary information for variations requiring
assessment (extended and standard timetables – monthly submission dates) .........29
12. Response to the request for supplementary information for variations requiring
assessment (reduced timetable – weekly submission dates) .................................31
13. VAMF/vPTMF – 1st phase ..................................................................................37
14. VAMF/vPTMF – 2nd phase ..................................................................................39
15. Centralised (initial applications) – 1st phase (accelerated assessment) ...................41
16. Responses to the list of questions (LoQ) – 2nd phase (accelerated assessment) ......43
17. Responses to the list of outstanding issues – 3rd phase (30-day assessment after
clock-stop for outstanding issues or after oral explanation) (accelerated assessment)
.....................................................................................................................45
第 2 页
Centralised (initial applications) – 1st phase (120-day assessment)
Deadline for Validation of Start (day 1) Rapporteur’s Co- Comments Draft list of Rapporteur’s Adoption of
submission1 dossier AR rapporteur’s from CVMP questions meeting list of
completed comments members (teleconference) questions
including peer (day 120)
review
2025
02/09/2025 17/09/2025 18/09/2025 26/11/2025 11/12/2025 26/12/2025 02/01/2026 07/01/2026 15/01/2026
30/09/2025 15/10/2025 16/10/2025 24/12/2025 08/01/2026 23/01/2026 30/01/2026 04/02/2026 12/02/2026
28/10/2025 12/11/2025 13/11/2025 21/01/2026 05/02/2026 20/02/2026 27/02/2026 04/03/2026 12/03/2026
02/12/2025 17/12/2025 18/12/2025 25/02/2026 12/03/2026 27/03/2026 03/04/2026 08/04/2026 16/04/2026
2026
06/01/2026 21/01/2026 22/01/2026 01/04/2026 16/04/2026 01/05/2026 08/05/2026 13/05/2026 21/05/2026
03/02/2026 18/02/2026 19/02/2026 29/04/2026 14/05/2026 29/05/2026 05/06/2026 10/06/2026 18/06/2026
03/03/2026 18/03/2026 19/03/2026 27/05/2026 11/06/2026 26/06/2026 03/07/2026 08/07/2026 16/07/2026
28/04/2026 13/05/2026 14/05/2026 22/07/2026 06/08/2026 21/08/2026 28/08/2026 02/09/2026 10/09/2026
26/05/2026 10/06/2026 11/06/2026 19/08/2026 03/09/2026 18/09/2026 25/09/2026 30/09/2026 08/10/2026
23/06/2026 08/07/2026 09/07/2026 16/09/2026 01/10/2026 16/10/2026 23/10/2026 28/10/2026 05/11/2026
21/07/2026 05/08/2026 06/08/2026 14/10/2026 29/10/2026 13/11/2026 20/11/2026 25/11/2026 03/12/2026
N/A N/A N/A N/A N/A N/A N/A N/A N/A
09/09/2026 23/09/2026 24/09/2026 02/12/2026 17/12/2026 04/01/2027 08/01/2027 13/01/2027 21/01/2027
08/10/2026 21/10/2026 22/10/2026 30/12/2026 14/01/2027 29/01/2027 05/02/2027 10/02/2027 18/02/2027
05/11/2026 18/11/2026 19/11/2026 27/01/2027 11/02/2027 26/02/2027 05/03/2027 10/03/2027 18/03/2027
03/12/2026 16/12/2026 17/12/2026 24/02/2027 11/03/2027 26/03/2027 02/04/2027 07/04/2027 15/04/2027
1 The Agency strongly recommends submitting the application up to 7 days before the published submission deadline.
第 3 页
Deadline for Validation of Start (day 1) Rapporteur’s Co- Comments Draft list of Rapporteur’s Adoption of
submission2 dossier AR rapporteur’s from CVMP questions meeting list of
completed comments members (teleconference) questions
including peer (day 120)
review
2027
05/01/2027 20/01/2027 21/01/2027 31/03/2027 15/04/2027 30/04/2027 07/05/2027 12/05/2027 20/05/2027
02/02/2027 17/02/2027 18/02/2027 28/04/2027 13/05/2027 28/05/2027 04/06/2027 09/06/2027 17/06/2027
02/03/2027 17/03/2027 18/03/2027 26/05/2027 10/06/2027 25/06/2027 02/07/2027 07/07/2027 15/07/2027
27/04/2027 12/05/2027 13/05/2027 21/07/2027 05/08/2027 20/08/2027 27/08/2027 01/09/2027 09/09/2027
25/05/2027 09/06/2027 10/06/2027 18/08/2027 02/09/2027 17/09/2027 24/09/2027 29/09/2027 07/10/2027
23/06/2027 08/07/2027 09/07/2027 16/09/2027 01/10/2027 15/10/2027 25/10/2027 28/10/2027 05/11/2027
20/07/2027 04/08/2027 05/08/2027 13/10/2027 28/10/2027 12/11/2027 19/11/2027 24/11/2027 02/12/2027
N/A N/A N/A N/A N/A N/A N/A N/A N/A
07/09/2027 22/09/2027 23/09/2027 01/12/2027 16/12/2027 03/01/2028 07/01/2028 12/01/2028 20/01/2028
05/10/2027 20/10/2027 21/10/2027 29/12/2027 13/01/2028 28/01/2028 04/02/2028 09/02/2028 17/02/2028
02/11/2027 17/11/2027 18/11/2027 26/01/2028 10/02/2028 25/02/2028 03/03/2028 08/03/2028 16/03/2028
29/11/2027 14/12/2027 15/12/2027 22/02/2028 08/03/2028 23/03/2028 30/03/2028 04/04/2028 12/04/2028
2028
03/01/2028 14/01/2028 17/01/2028 23/03/2028 07/04/2028 21/04/2028 28/04/2028 04/05/2028 12/05/2028
01/02/2028 16/02/2028 17/02/2028 26/04/2028 11/05/2028 26/05/2028 02/06/2028 07/06/2028 15/06/2028
29/02/2028 15/03/2028 16/03/2028 24/05/2028 08/06/2028 23/06/2028 30/06/2028 05/07/2028 13/07/2028
25/04/2028 10/05/2028 11/05/2028 19/07/2028 03/08/2028 18/08/2028 25/08/2028 30/08/2028 07/09/2028
23/05/2028 07/06/2028 08/06/2028 16/08/2028 31/08/2028 15/09/2028 22/09/2028 27/09/2028 05/10/2028
27/06/2028 12/07/2028 13/07/2028 20/09/2028 05/10/2028 20/10/2028 27/10/2028 01/11/2028 09/11/2028
25/07/2028 09/08/2028 10/08/2028 18/10/2028 02/11/2028 17/11/2028 24/11/2028 29/11/2028 07/12/2028
N/A N/A N/A N/A N/A N/A N/A N/A N/A
2 The Agency strongly recommends submitting the application up to 7 days before the published submission deadline.
EMA/219234/2026 Page 3/46
第 4 页
MRL applications – 1st phase (120-day assessment)
Submission Validation of Start (day 1) Rapporteur’s Co- Comments Draft list of Rapporteur’s Adoption of
date dossier AR rapporteur’s from CVMP questions meeting list of
completed comments members (teleconference) questions
including peer (day 120)
review
2025
29/08/2025 17/09/2025 18/09/2025 26/11/2025 11/12/2025 26/12/2025 02/01/2026 07/01/2026 15/01/2026
26/09/2025 15/10/2025 16/10/2025 24/12/2025 08/01/2026 23/01/2026 30/01/2026 04/02/2026 12/02/2026
24/10/2025 12/11/2025 13/11/2025 21/01/2026 05/02/2026 20/02/2026 27/02/2026 04/03/2026 12/03/2026
28/11/2025 17/12/2025 18/12/2025 25/02/2026 12/03/2026 27/03/2026 03/04/2026 08/04/2026 16/04/2026
2026
02/01/2026 21/01/2026 22/01/2026 01/04/2026 16/04/2026 01/05/2026 08/05/2026 13/05/2026 21/05/2026
30/01/2026 18/02/2026 19/02/2026 29/04/2026 14/05/2026 29/05/2026 05/06/2026 10/06/2026 18/06/2026
27/02/2026 18/03/2026 19/03/2026 27/05/2026 11/06/2026 26/06/2026 03/07/2026 08/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A N/A N/A N/A
24/04/2026 13/05/2026 14/05/2026 22/07/2026 06/08/2026 21/08/2026 28/08/2026 02/09/2026 10/09/2026
22/05/2026 10/06/2026 11/06/2026 19/08/2026 03/09/2026 18/09/2026 25/09/2026 30/09/2026 08/10/2026
19/06/2026 08/07/2026 09/07/2026 16/09/2026 01/10/2026 16/10/2026 23/10/2026 28/10/2026 05/11/2026
17/07/2026 05/08/2026 06/08/2026 14/10/2026 29/10/2026 13/11/2026 20/11/2026 25/11/2026 03/12/2026
04/09/2026 23/09/2026 24/09/2026 02/12/2026 17/12/2026 04/01/2027 08/01/2027 13/01/2027 21/01/2027
02/10/2026 21/10/2026 22/10/2026 30/12/2026 14/01/2027 29/01/2027 05/02/2027 10/02/2027 18/02/2027
30/10/2026 18/11/2026 19/11/2026 27/01/2027 11/02/2027 26/02/2027 05/03/2027 10/03/2027 18/03/2027
27/11/2026 16/12/2026 17/12/2026 24/02/2027 11/03/2027 26/03/2027 02/04/2027 07/04/2027 15/04/2027
31/12/2026 20/01/2027 21/01/2027 31/03/2027 15/04/2027 30/04/2027 07/05/2027 12/05/2027 20/05/2027
EMA/219234/2026 Page 4/46
第 5 页
Submission Validation of Start (day 1) Rapporteur’s Co- Comments Draft list of Rapporteur’s Adoption of
date dossier AR rapporteur’s from CVMP questions meeting list of
completed comments members (teleconference) questions
including peer (day 120)
review
2027
29/01/2027 17/02/2027 18/02/2027 28/04/2027 13/05/2027 28/05/2027 04/06/2027 09/06/2027 17/06/2027
26/02/2027 17/03/2027 18/03/2027 26/05/2027 10/06/2027 25/06/2027 02/07/2027 07/07/2027 15/07/2027
N/A N/A N/A N/A N/A N/A N/A N/A N/A
23/04/2027 12/05/2027 13/05/2027 21/07/2027 05/08/2027 20/08/2027 27/08/2027 01/09/2027 09/09/2027
21/05/2027 09/06/2027 10/06/2027 18/08/2027 02/09/2027 17/09/2027 24/09/2027 29/09/2027 07/10/2027
18/06/2027 08/07/2027 09/07/2027 16/09/2027 01/10/2027 15/10/2027 22/10/2027 28/10/2027 05/11/2027
16/07/2027 04/08/2027 05/08/2027 13/10/2027 28/10/2027 12/11/2027 19/11/2027 24/11/2027 02/12/2027
03/09/2027 22/09/2027 23/09/2027 01/12/2027 16/12/2027 03/01/2028 07/01/2028 12/01/2028 20/01/2028
01/10/2027 20/10/2027 21/10/2027 29/12/2027 13/01/2028 28/01/2028 04/02/2028 09/02/2028 17/02/2028
29/10/2027 17/11/2027 18/11/2027 26/01/2028 10/02/2028 25/02/2028 03/03/2028 08/03/2028 16/03/2028
25/11/2027 14/12/2027 15/12/2027 22/02/2028 08/03/2028 23/03/2028 30/03/2028 04/04/2028 12/04/2028
23/12/2027 13/01/2028 14/01/2028 23/03/2028 07/04/2028 21/04/2028 28/04/2028 04/05/2028 12/05/2028
2028
28/01/2028 16/02/2028 17/02/2028 26/04/2028 11/05/2028 26/05/2028 02/06/2028 07/06/2028 15/06/2028
25/02/2028 15/03/2028 16/03/2028 24/05/2028 08/06/2028 23/06/2028 30/06/2028 05/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A N/A N/A N/A
21/04/2028 10/05/2028 11/05/2028 19/07/2028 03/08/2028 18/08/2028 25/08/2028 30/08/2028 07/09/2028
19/05/2028 07/06/2028 08/06/2028 16/08/2028 31/08/2028 15/09/2028 22/09/2028 27/09/2028 05/10/2028
23/06/2028 12/07/2028 13/07/2028 20/09/2028 05/10/2028 20/10/2028 27/10/2028 01/11/2028 09/11/2028
21/07/2028 09/08/2028 10/08/2028 18/10/2028 02/11/2028 17/11/2028 24/11/2028 29/11/2028 07/12/2028
EMA/219234/2026 Page 5/46
第 6 页
Responses to the list of questions (LoQ)3 – 2nd phase (60-day assessment after clock-stop
for responses)
Submission of Clock restart (day QRD comments Joint AR on CVMP & peer Rapporteur’s Adoption of list of
response to LoQ 121) response to LoQ review comments meeting/ outstanding issues
teleconference (if and decision on
necessary) oral explanation
(day 180)
2025
14/11/2025 17/11/2025 06/12/2025 26/12/2025 05/01/2026 07/01/2026 15/01/2026
12/12/2025 15/12/2025 03/01/2026 23/01/2026 02/02/2026 04/02/2026 12/02/2026
2026
09/01/2026 12/01/2026 31/01/2026 20/02/2026 02/03/2026 04/03/2026 12/03/2026
13/02/2026 16/02/2026 07/03/2026 27/03/2026 06/04/2026 08/04/2026 16/04/2026
20/03/2026 23/03/2026 11/04/2026 01/05/2026 11/05/2026 13/05/2026 21/05/2026
17/04/2026 20/04/2026 09/05/2026 29/05/2026 08/06/2026 10/06/2026 18/06/2026
15/05/2026 18/05/2026 06/06/2026 26/06/2026 06/07/2026 08/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A N/A
10/07/2026 13/07/2026 01/08/2026 21/08/2026 31/08/2026 02/09/2026 10/09/2026
07/08/2026 10/08/2026 29/08/2026 18/09/2026 28/09/2026 30/09/2026 08/10/2026
04/09/2026 07/09/2026 26/09/2026 16/10/2026 26/10/2026 28/10/2026 05/11/2026
02/10/2026 05/10/2026 24/10/2026 13/11/2026 23/11/2026 25/11/2026 03/12/2026
20/11/2026 23/11/2026 11/12/2026 04/01/2027 11/01/2027 13/01/2027 21/01/2027
18/12/2026 21/12/2026 08/01/2027 29/01/2027 08/02/2027 10/02/2027 18/02/2027
2027
15/01/2027 18/01/2027 05/02/2027 26/02/2027 08/03/2027 10/03/2027 18/03/2027
12/02/2027 15/02/2027 05/03/2027 26/03/2027 05/04/2027 07/04/2027 15/04/2027
3 Includes responses for MRL application (2nd phase) and responses for Informed Consent (2nd phase)
EMA/219234/2026 Page 6/46
第 7 页
Submission of Clock restart (day QRD comments Joint AR on CVMP & peer Rapporteur’s Adoption of list of
response to LoQ 121) response to LoQ review comments meeting/ outstanding issues
teleconference (if and decision on
necessary) oral explanation
(day 180)
19/03/2027 22/03/2027 09/04/2027 30/04/2027 10/05/2027 12/05/2027 20/05/2027
16/04/2027 19/04/2027 07/05/2027 28/05/2027 07/06/2027 09/06/2027 17/06/2027
14/05/2027 17/05/2027 04/06/2027 25/06/2027 05/07/2027 07/07/2027 15/07/2027
N/A N/A N/A N/A N/A N/A N/A
09/07/2027 12/07/2027 30/07/2027 20/08/2027 30/08/2027 01/09/2027 09/09/2027
06/08/2027 09/08/2027 27/08/2027 17/09/2027 27/09/2027 29/09/2027 07/10/2027
03/09/2027 06/09/2027 24/09/2027 15/10/2027 26/10/2027 28/10/2027 05/11/2027
01/10/2027 04/10/2027 22/10/2027 12/11/2027 22/11/2027 24/11/2027 02/12/2027
19/11/2027 22/11/2027 10/12/2027 03/01/2028 10/01/2028 12/01/2028 20/01/2028
17/12/2027 20/12/2027 07/01/2028 28/01/2028 07/02/2028 09/02/2028 17/02/2028
2028
14/01/2028 17/01/2028 04/02/2028 25/02/2028 06/03/2028 08/03/2028 16/03/2028
11/02/2028 14/02/2028 03/03/2028 23/03/2028 03/04/2028 04/04/2028 12/04/2028
13/03/2028 14/03/2028 03/04/2028 24/04/2028 02/05/2028 04/05/2028 12/05/2028
14/04/2028 17/04/2028 05/05/2028 26/05/2028 05/06/2028 07/06/2028 15/06/2028
12/05/2028 15/05/2028 02/06/2028 23/06/2028 03/07/2028 05/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A N/A
07/07/2028 10/07/2028 28/07/2028 18/08/2028 28/08/2028 30/08/2028 07/09/2028
04/08/2028 07/08/2028 25/08/2028 15/09/2028 25/09/2028 27/09/2028 05/10/2028
08/09/2028 11/09/2028 28/09/2028 20/10/2028 30/10/2028 01/11/2028 09/11/2028
06/10/2028 09/10/2028 27/10/2028 17/11/2028 27/11/2028 29/11/2028 07/12/2028
EMA/219234/2026 Page 7/46
第 8 页
Responses to the list of outstanding issues4 – 3rd phase (30-day assessment after clock-
stop for outstanding issues or after oral explanation)
Submission date Clock restart (day Joint AR Draft CVMP AR CVMP comments on Adoption of opinion
181) joint AR
2026
13/01/2026 14/01/2026 23/01/2026 23/01/2026 30/01/2026 12/02/2026
10/02/2026 11/02/2026 20/02/2026 20/02/2026 27/02/2026 12/03/2026
17/03/2026 18/03/2026 27/03/2026 27/03/2026 03/04/2026 16/04/2026
21/04/2026 22/04/2026 01/05/2026 01/05/2026 08/05/2026 21/05/2026
19/05/2026 20/05/2026 29/05/2026 29/05/2026 05/06/2026 18/06/2026
16/06/2026 17/06/2026 26/06/2026 26/06/2026 03/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A
11/08/2026 12/08/2026 21/08/2026 21/08/2026 28/08/2026 10/09/2026
08/09/2026 09/09/2026 18/09/2026 18/09/2026 25/09/2026 08/10/2026
06/10/2026 07/10/2026 16/10/2026 16/10/2026 23/10/2026 05/11/2026
03/11/2026 04/11/2026 13/11/2026 13/11/2026 20/11/2026 03/12/2026
18/12/2026 21/12/2026 04/01/2027 04/01/2027 08/01/2027 21/01/2027
2027
19/01/2027 20/01/2027 29/01/2027 29/01/2027 05/02/2027 18/02/2027
16/02/2027 17/02/2027 26/02/2027 26/02/2027 05/03/2027 18/03/2027
16/03/2027 17/03/2027 26/03/2027 26/03/2027 02/04/2027 15/04/2027
20/04/2027 21/04/2027 30/04/2027 30/04/2027 07/05/2027 20/05/2027
18/05/2027 19/05/2027 28/05/2027 28/05/2027 04/06/2027 17/06/2027
15/06/2027 16/06/2027 25/06/2027 25/06/2027 02/07/2027 15/07/2027
10/08/2027 11/08/2027 20/08/2027 20/08/2027 27/08/2027 09/09/2027
4 Includes responses for MRL applications and responses for Informed Consent (3rd Phase)
EMA/219234/2026 Page 8/46
第 9 页
Submission date Clock restart (day Joint AR Draft CVMP AR CVMP comments on Adoption of opinion
181) joint AR
07/09/2027 08/09/2027 17/09/2027 17/09/2027 24/09/2027 07/10/2027
06/10/2027 07/10/2027 15/10/2027 15/10/2027 22/10/2027 05/11/2027
02/11/2027 03/11/2027 12/11/2027 12/11/2027 19/11/2027 02/12/2027
17/12/2027 20/12/2027 03/01/2028 03/01/2028 07/01/2028 20/01/2028
2028
18/01/2028 19/01/2028 28/01/2028 28/01/2028 04/02/2028 17/02/2028
15/02/2028 16/02/2028 25/02/2028 25/02/2028 03/03/2028 16/03/2028
13/03/2028 14/03/2028 23/03/2028 23/03/2028 30/03/2028 12/04/2028
11/04/2028 12/04/2028 21/04/2028 21/04/2028 28/04/2028 12/05/2028
16/05/2028 17/05/2028 26/05/2028 26/05/2028 02/06/2028 15/06/2028
13/06/2028 14/06/2028 23/06/2028 23/06/2028 30/06/2028 13/07/2028
08/08/2028 09/08/2028 18/08/2028 18/08/2028 25/08/2028 07/09/2028
05/09/2028 06/09/2028 15/09/2028 15/09/2028 22/09/2028 05/10/2028
10/10/2028 11/10/2028 20/10/2028 20/10/2028 27/10/2028 09/11/2028
07/11/2028 08/11/2028 17/11/2028 17/11/2028 24/11/2028 07/12/2028
EMA/219234/2026 Page 9/46
第 10 页
Responses to the list of questions (LoQ) further to the establishment of provisional MRLs
(90-day assessment after clock-stop for responses)
Submission date Clock start (day 1) CVMP rapporteur Co-rapporteur critique CVMP comments/ peer Adoption of opinion
assessment report review
2025
17/10/2025 18/10/2025 01/12/2025 16/12/2025 26/12/2025 15/01/2026
14/11/2025 15/11/2025 29/12/2025 13/01/2026 23/01/2026 12/02/2026
12/12/2025 13/12/2025 26/01/2026 10/02/2026 20/02/2026 12/03/2026
2026
16/01/2026 17/01/2026 02/03/2026 17/03/2026 27/03/2026 16/04/2026
20/02/2026 21/02/2026 06/04/2026 21/04/2026 01/05/2026 21/05/2026
20/03/2026 21/03/2026 04/05/2026 19/05/2026 29/05/2026 18/06/2026
17/04/2026 18/04/2026 01/06/2026 16/06/2026 26/06/2026 16/07/2026
N/A N/A N/A N/A N/A N/A
12/06/2026 13/06/2026 27/07/2026 11/08/2026 21/08/2026 10/09/2026
10/07/2026 11/07/2026 24/08/2026 08/09/2026 18/09/2026 08/10/2026
07/08/2026 08/08/2026 21/09/2026 06/10/2026 16/10/2026 05/11/2026
04/09/2026 05/09/2026 19/10/2026 03/11/2026 13/11/2026 03/12/2026
23/10/2026 26/10/2026 07/12/2026 22/12/2026 05/01/2027 21/01/2027
20/11/2026 23/11/2026 04/01/2027 19/01/2027 29/01/2027 18/02/2027
18/12/2026 21/12/2026 01/02/2027 16/02/2027 26/02/2027 18/03/2027
EMA/219234/2026 Page 10/46
第 11 页
Submission date Clock start (day 1) CVMP rapporteur Co-rapporteur critique CVMP comments/ peer Adoption of opinion
assessment report review
2027
15/01/2027 18/01/2027 01/03/2027 16/03/2027 26/03/2027 15/04/2027
19/02/2027 22/02/2027 05/04/2027 20/04/2027 30/04/2027 20/05/2027
19/03/2027 22/03/2027 03/05/2027 18/05/2027 28/05/2027 17/06/2027
16/04/2027 19/04/2027 31/05/2027 15/06/2027 25/06/2027 15/07/2027
N/A N/A N/A N/A N/A N/A
11/06/2027 14/06/2027 26/07/2027 10/08/2027 20/08/2027 09/09/2027
09/07/2027 12/07/2027 23/08/2027 07/09/2027 17/09/2027 07/10/2027
06/08/2027 09/08/2027 21/09/2027 06/10/2027 15/10/2027 05/11/2027
03/09/2027 06/09/2027 18/10/2027 02/11/2027 12/11/2027 02/12/2027
22/10/2027 25/10/2027 06/12/2027 21/12/2027 05/01/2028 20/01/2028
19/11/2027 22/11/2027 05/01/2028 18/01/2028 28/01/2028 17/02/2028
17/12/2027 20/12/2027 31/01/2028 15/02/2028 25/02/2028 16/03/2028
2028
13/01/2028 14/01/2028 28/02/2028 13/03/2028 23/03/2028 12/04/2028
11/02/2028 14/02/2028 28/03/2028 12/04/2028 24/04/2028 12/05/2028
17/03/2028 20/03/2028 01/05/2028 16/05/2028 26/05/2028 15/06/2028
14/04/2028 17/04/2028 29/05/2028 13/06/2028 23/06/2028 13/07/2028
N/A N/A N/A N/A N/A N/A
09/06/2028 12/06/2028 24/07/2028 08/08/2028 18/08/2028 07/09/2028
07/07/2028 10/07/2028 21/08/2028 05/09/2028 15/09/2028 05/10/2028
11/08/2028 14/08/2028 25/09/2028 10/10/2028 20/10/2028 09/11/2028
08/09/2028 11/09/2028 23/10/2028 07/11/2028 17/11/2028 07/12/2028
EMA/219234/2026 Page 11/46
第 12 页
Informed consent – 1st phase (60-day assessment)
Submission Validation of Start (day 1) Rapporteur’s Co-rapporteur’s CVMP Rapporteur’s Adoption of
date dossier AR comments comments revised opinion (or
completed assessment adoption of list
report of questions (day
60)
2025
03/11/2025 17/11/2025 18/11/2025 17/12/2025 24/12/2025 30/12/2025 05/01/2026 15/01/2026
01/12/2025 15/12/2025 16/12/2025 14/01/2026 21/01/2026 27/01/2026 02/02/2026 12/02/2026
29/12/2025 12/01/2026 13/01/2026 11/02/2026 18/02/2026 24/02/2026 02/03/2026 12/03/2026
2026
02/02/2026 16/02/2026 17/02/2026 18/03/2026 25/03/2026 31/03/2026 06/04/2026 16/04/2026
09/03/2026 23/03/2026 24/03/2026 22/04/2026 29/04/2026 05/05/2026 11/05/2026 21/05/2026
06/04/2026 20/04/2026 21/04/2026 20/05/2026 27/05/2026 02/06/2026 08/06/2026 18/06/2026
04/05/2026 18/05/2026 19/05/2026 17/06/2026 24/06/2026 30/06/2026 06/07/2026 16/07/2026
29/06/2026 13/07/2026 14/07/2026 12/08/2026 19/08/2026 25/08/2026 31/08/2026 10/09/2026
27/07/2026 10/08/2026 11/08/2026 09/09/2026 16/09/2026 22/09/2026 28/09/2026 08/10/2026
24/08/2026 07/09/2026 08/09/2026 07/10/2026 14/10/2026 20/10/2026 26/10/2026 05/11/2026
21/09/2026 05/10/2026 06/10/2026 04/11/2026 11/11/2026 17/11/2026 23/11/2026 03/12/2026
N/A N/A N/A N/A N/A N/A N/A N/A
09/11/2026 23/11/2026 24/11/2026 23/12/2026 04/01/2027 07/01/2027 11/01/2027 21/01/2027
07/12/2026 18/12/2026 21/12/2026 20/01/2027 27/01/2027 02/02/2027 08/02/2027 18/02/2027
2027
04/01/2027 18/01/2027 19/01/2027 17/02/2027 24/02/2027 02/03/2027 08/03/2027 18/03/2027
01/02/2027 15/02/2027 16/02/2027 17/03/2027 24/03/2027 30/03/2027 05/04/2027 15/04/2027
08/03/2027 22/03/2027 23/03/2027 21/04/2027 28/04/2027 04/05/2027 10/05/2027 20/05/2027
05/04/2027 19/04/2027 20/04/2027 19/05/2027 26/05/2027 01/06/2027 07/06/2027 17/06/2027
EMA/219234/2026 Page 12/46
第 13 页
Submission Validation of Start (day 1) Rapporteur’s Co-rapporteur’s CVMP Rapporteur’s Adoption of
date dossier AR comments comments revised opinion (or
completed assessment adoption of list
report of questions (day
60)
03/05/2027 17/05/2027 18/05/2027 16/06/2027 23/06/2027 29/06/2027 05/07/2027 15/07/2027
28/06/2027 12/07/2027 13/07/2027 11/08/2027 18/08/2027 24/08/2027 30/08/2027 09/09/2027
26/07/2027 09/08/2027 10/08/2027 08/09/2027 15/09/2027 21/09/2027 27/09/2027 07/10/2027
24/08/2027 07/09/2027 08/09/2027 07/10/2027 14/10/2027 20/10/2027 26/10/2027 05/11/2027
21/09/2027 04/10/2027 05/10/2027 03/11/2027 10/11/2027 16/11/2027 22/11/2027 02/12/2027
N/A N/A N/A N/A N/A N/A N/A N/A
08/11/2027 22/11/2027 23/11/2027 22/12/2027 03/01/2028 06/01/2028 10/01/2028 20/01/2028
06/12/2027 20/12/2027 21/12/2027 19/01/2028 26/01/2028 01/02/2028 07/02/2028 17/02/2028
2028
03/01/2028 17/01/2028 18/01/2028 16/02/2028 23/02/2028 29/02/2028 06/03/2028 16/03/2028
31/01/2028 13/02/2028 14/02/2028 14/03/2028 21/03/2028 27/03/2028 03/04/2028 12/04/2028
29/02/2028 14/03/2028 15/03/2028 13/04/2028 20/04/2028 26/04/2028 02/05/2028 12/05/2028
03/04/2028 17/04/2028 18/04/2028 17/05/2028 24/05/2028 30/05/2028 05/06/2028 15/06/2028
01/05/2028 15/05/2028 16/05/2028 14/06/2028 21/06/2028 27/06/2028 03/07/2028 13/07/2028
26/06/2028 10/07/2028 11/07/2028 09/08/2028 16/08/2028 22/08/2028 28/08/2028 07/09/2028
24/07/2028 07/08/2028 08/08/2028 06/09/2028 13/09/2028 19/09/2028 25/09/2028 05/10/2028
28/08/2028 11/09/2028 12/09/2028 11/10/2028 18/10/2028 24/10/2028 30/10/2028 09/11/2028
25/09/2028 09/10/2028 10/10/2028 08/11/2028 15/11/2028 21/11/2028 27/11/2028 07/12/2028
EMA/219234/2026 Page 13/46
第 14 页
Variations requiring assessment (extended timetable) – 1st phase
Submission date Validation of Start Rapporteurs’ AR Co-rapporteur’s CVMP Rapporteurs’ Adoption of
dossier comments comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
2025
03/11/2025 17/11/2025 18/11/2025 26/12/2025 01/01/2026 06/01/2026 09/01/2026 15/01/2026
01/12/2025 15/12/2025 16/12/2025 23/01/2026 29/01/2026 03/02/2026 06/02/2026 12/02/2026
29/12/2025 12/01/2026 13/01/2026 20/02/2026 26/02/2026 03/03/2026 06/03/2026 12/03/2026
2026
02/02/2026 16/02/2026 17/02/2026 25/03/2026 31/03/2026 07/04/2026 10/04/2026 16/04/2026
09/03/2026 23/03/2026 24/03/2026 01/05/2026 07/05/2026 12/05/2026 15/05/2026 21/05/2026
06/04/2026 20/04/2026 21/04/2026 29/05/2026 04/06/2026 09/06/2026 12/06/2026 18/06/2026
04/05/2026 18/05/2026 19/05/2026 26/06/2026 02/07/2026 07/07/2026 10/07/2026 16/07/2026
29/06/2026 13/07/2026 14/07/2026 21/08/2026 27/08/2026 01/09/2026 04/09/2026 10/09/2026
27/07/2026 10/08/2026 11/08/2026 18/09/2026 24/09/2026 29/09/2026 02/10/2026 08/10/2026
24/08/2026 07/09/2026 08/09/2026 16/10/2026 22/10/2026 27/10/2026 30/10/2026 05/11/2026
21/09/2026 05/10/2026 06/10/2026 13/11/2026 19/11/2026 24/11/2026 27/11/2026 03/12/2026
09/11/2026 23/11/2026 24/11/2026 04/01/2027 07/01/2027 12/01/2027 15/01/2027 21/01/2027
07/12/2026 18/12/2026 21/12/2026 29/01/2027 04/02/2027 09/02/2027 12/02/2027 18/02/2027
2027
04/01/2027 18/01/2027 19/01/2027 26/02/2027 04/03/2027 09/03/2027 12/03/2027 18/03/2027
01/02/2027 15/02/2027 16/02/2027 26/03/2027 01/04/2027 06/04/2027 09/04/2027 15/04/2027
08/03/2027 22/03/2027 23/03/2027 30/04/2027 06/05/2027 11/05/2027 14/05/2027 20/05/2027
05/04/2027 19/04/2027 20/04/2027 28/05/2027 03/06/2027 08/06/2027 11/06/2027 17/06/2027
03/05/2027 17/05/2027 18/05/2027 25/06/2027 01/07/2027 06/07/2027 09/07/2027 15/07/2027
EMA/219234/2026 Page 14/46
第 15 页
Submission date Validation of Start Rapporteurs’ AR Co-rapporteur’s CVMP Rapporteurs’ Adoption of
dossier comments comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
28/06/2027 12/07/2027 13/07/2027 20/08/2027 26/08/2027 31/08/2027 03/09/2027 09/09/2027
26/07/2027 09/08/2027 10/08/2027 17/09/2027 23/09/2027 28/09/2027 01/10/2027 07/10/2027
24/08/2027 07/09/2027 08/09/2027 15/10/2027 22/10/2027 27/10/2027 29/10/2027 05/11/2027
20/09/2027 04/10/2027 05/10/2027 12/11/2027 18/11/2027 23/11/2027 26/11/2027 02/12/2027
08/11/2027 22/11/2027 23/11/2027 31/12/2027 06/01/2028 11/01/2028 14/01/2028 20/01/2028
06/12/2027 17/12/2027 20/12/2027 28/01/2028 03/02/2028 08/02/2028 11/02/2028 17/02/2028
2028
03/01/2028 17/01/2028 18/01/2028 25/02/2028 02/03/2028 07/03/2028 10/03/2028 16/03/2028
31/01/2028 13/02/2028 14/02/2028 23/03/2028 29/03/2028 03/04/2028 06/04/2028 12/04/2028
29/02/2028 14/03/2028 15/03/2028 21/04/2028 28/04/2028 03/05/2028 05/05/2028 12/05/2028
03/04/2028 17/04/2028 18/04/2028 26/05/2028 01/06/2028 06/06/2028 09/06/2028 15/06/2028
01/05/2028 15/05/2028 16/05/2028 23/06/2028 29/06/2028 04/07/2028 07/07/2028 13/07/2028
26/06/2028 10/07/2028 11/07/2028 18/08/2028 24/08/2028 29/08/2028 01/09/2028 07/09/2028
24/07/2028 07/08/2028 08/08/2028 15/09/2028 21/09/2028 26/09/2028 29/09/2028 05/10/2028
28/08/2028 11/09/2028 12/09/2028 20/10/2028 26/10/2028 31/10/2028 03/11/2028 09/11/2028
25/09/2028 09/10/2028 10/10/2028 17/11/2028 23/11/2028 28/11/2028 01/12/2028 07/12/2028
EMA/219234/2026 Page 15/46
第 16 页
Variations requiring assessment (standard timetable) – 1st phase
Submission date Validation of Start Rapporteurs’ AR Co-rapporteur’s CVMP Rapporteurs’ Adoption of
dossier comments comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
03/11/2025 17/11/2025 18/11/2025 17/12/2025 24/12/2025 30/12/2025 06/01/2026 15/01/2026
01/12/2025 15/12/2025 16/12/2025 14/01/2026 21/01/2026 27/01/2026 03/02/2026 12/02/2026
29/12/2025 12/01/2026 13/01/2026 11/02/2026 18/02/2026 24/02/2026 03/03/2026 12/03/2026
2026
02/02/2026 16/02/2026 17/02/2026 18/03/2026 25/03/2026 31/03/2026 07/04/2026 16/04/2026
09/03/2026 23/03/2026 24/03/2026 22/04/2026 29/04/2026 05/05/2026 12/05/2026 21/05/2026
06/04/2026 20/04/2026 21/04/2026 20/05/2026 27/05/2026 02/06/2026 09/06/2026 18/06/2026
04/05/2026 18/05/2026 19/05/2026 17/06/2026 24/06/2026 30/06/2026 07/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A N/A N/A
29/06/2026 13/07/2026 14/07/2026 12/08/2026 19/08/2026 25/08/2026 01/09/2026 10/09/2026
27/07/2026 10/08/2026 11/08/2026 09/09/2026 16/09/2026 22/09/2026 29/09/2026 08/10/2026
24/08/2026 07/09/2026 08/09/2026 07/10/2026 14/10/2026 20/10/2026 27/10/2026 05/11/2026
21/09/2026 05/10/2026 06/10/2026 04/11/2026 11/11/2026 17/11/2026 24/11/2026 03/12/2026
09/11/2026 23/11/2026 24/11/2026 23/12/2026 04/01/2027 07/01/2027 12/01/2027 21/01/2027
07/12/2026 18/12/2026 21/12/2026 20/01/2027 27/01/2027 02/02/2027 09/02/2027 18/02/2027
2027
04/01/2027 18/01/2027 19/01/2027 17/02/2027 24/02/2027 02/03/2027 09/03/2027 18/03/2027
01/02/2027 15/02/2027 16/02/2027 17/03/2027 24/03/2027 31/03/2027 06/04/2027 15/04/2027
08/03/2027 22/03/2027 23/03/2027 21/04/2027 28/04/2027 04/05/2027 11/05/2027 20/05/2027
05/04/2027 19/04/2027 20/04/2027 19/05/2027 26/05/2027 01/06/2027 08/06/2027 17/06/2027
03/05/2027 17/05/2027 18/05/2027 16/06/2027 23/06/2027 29/06/2027 06/07/2027 15/07/2027
EMA/219234/2026 Page 16/46
第 17 页
Submission date Validation of Start Rapporteurs’ AR Co-rapporteur’s CVMP Rapporteurs’ Adoption of
dossier comments comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
28/06/2027 12/07/2027 13/07/2027 11/08/2027 18/08/2027 24/08/2027 31/08/2027 09/09/2027
26/07/2027 09/08/2027 10/08/2027 08/09/2027 15/09/2027 21/09/2027 28/09/2027 07/10/2027
24/08/2027 07/09/2027 08/09/2027 07/10/2027 14/10/2027 20/10/2027 27/10/2027 05/11/2027
20/09/2027 04/10/2027 05/10/2027 03/11/2027 10/11/2027 16/11/2027 23/11/2027 02/12/2027
08/11/2027 22/11/2027 23/11/2027 22/12/2027 03/01/2028 06/01/2028 11/01/2028 20/01/2028
06/12/2027 17/12/2027 20/12/2027 19/01/2028 26/01/2028 01/02/2028 08/02/2028 17/02/2028
2028
03/01/2028 17/01/2028 18/01/2028 16/02/2028 23/02/2028 29/02/2028 07/03/2028 16/03/2028
31/01/2028 13/02/2028 14/02/2028 14/03/2028 21/03/2028 27/03/2028 03/04/2028 12/04/2028
29/02/2028 14/03/2028 15/03/2028 13/04/2028 20/04/2028 26/04/2028 03/05/2028 12/05/2028
03/04/2028 18/04/2028 19/04/2028 17/05/2028 24/05/2028 30/05/2028 06/06/2028 15/06/2028
01/05/2028 15/05/2028 16/05/2028 14/06/2028 21/06/2028 27/06/2028 04/07/2028 13/07/2028
26/06/2028 10/07/2028 11/07/2028 09/08/2028 16/08/2028 22/08/2028 29/08/2028 07/09/2028
24/07/2028 07/08/2028 08/08/2028 06/09/2028 13/09/2028 19/09/2028 26/09/2028 05/10/2028
28/08/2028 11/09/2028 12/09/2028 11/10/2028 18/10/2028 24/10/2028 31/10/2028 09/11/2028
25/09/2028 09/10/2028 10/10/2028 08/11/2028 15/11/2028 21/11/2028 28/11/2028 07/12/2028
EMA/219234/2026 Page 17/46
第 18 页
Variations requiring assessment5 (reduced timetable – weekly submissions) – 1st phase
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
2026
05/01/2026 20/01/2026 21/01/2026 05/02/2026 09/02/2026 11/02/2026 19/02/2026
12/01/2026 27/01/2026 28/01/2026 12/02/2026 16/02/2026 18/02/2026 26/02/2026
19/01/2026 03/02/2026 04/02/2026 19/02/2026 23/02/2026 25/02/2026 05/03/2026
26/01/2026 10/02/2026 11/02/2026 26/02/2026 02/03/2026 04/03/2026 12/03/2026
02/02/2026 17/02/2026 18/02/2026 05/03/2026 09/03/2026 11/03/2026 19/03/2026
09/02/2026 24/02/2026 25/02/2026 12/03/2026 16/03/2026 18/03/2026 26/03/2026
16/02/2026 03/03/2026 04/03/2026 19/03/2026 23/03/2026 25/03/2026 02/04/2026
23/02/2026 10/03/2026 11/03/2026 26/03/2026 30/03/2026 01/04/2026 09/04/2026
02/03/2026 17/03/2026 18/03/2026 02/04/2026 06/04/2026 08/04/2026 16/04/2026
09/03/2026 24/03/2026 25/03/2026 09/04/2026 13/04/2026 15/04/2026 23/04/2026
16/03/2026 31/03/2026 01/04/2026 16/04/2026 20/04/2026 22/04/2026 30/04/2026
23/03/2026 07/04/2026 08/04/2026 23/04/2026 27/04/2026 29/04/2026 07/05/2026
30/03/2026 14/04/2026 15/04/2026 30/04/2026 04/05/2026 06/05/2026 14/05/2026
06/04/2026 21/04/2026 22/04/2026 07/05/2026 11/05/2026 13/05/2026 21/05/2026
13/04/2026 28/04/2026 29/04/2026 14/05/2026 18/05/2026 20/05/2026 28/05/2026
20/04/2026 05/05/2026 06/05/2026 21/05/2026 25/05/2026 27/05/2026 04/06/2026
27/04/2026 12/05/2026 13/05/2026 28/05/2026 01/06/2026 03/06/2026 11/06/2026
04/05/2026 19/05/2026 20/05/2026 04/06/2026 08/06/2026 10/06/2026 18/06/2026
11/05/2026 26/05/2026 27/05/2026 11/06/2026 15/06/2026 17/06/2026 25/06/2026
5 Including WS procedures of centrally authorised products (CAPs) only
EMA/219234/2026 Page 18/46
第 19 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
18/05/2026 02/06/2026 03/06/2026 18/06/2026 22/06/2026 24/06/2026 02/07/2026
25/05/2026 09/06/2026 10/06/2026 25/06/2026 29/06/2026 01/07/2026 09/07/2026
01/06/2026 16/06/2026 17/06/2026 02/07/2026 06/07/2026 08/07/2026 16/07/2026
08/06/2026 23/06/2026 24/06/2026 09/07/2026 13/07/2026 15/07/2026 23/07/2026
15/06/2026 30/06/2026 01/07/2026 16/07/2026 20/07/2026 22/07/2026 30/07/2026
22/06/2026 07/07/2026 08/07/2026 23/07/2026 27/07/2026 29/07/2026 06/08/2026
N/A N/A N/A N/A N/A N/A N/A
27/07/2026 11/08/2026 12/08/2026 27/08/2026 31/08/2026 02/09/2026 10/09/2026
03/08/2026 18/08/2026 19/08/2026 03/09/2026 07/09/2026 09/09/2026 17/09/2026
10/08/2026 25/08/2026 26/08/2026 10/09/2026 14/09/2026 16/09/2026 24/09/2026
17/08/2026 01/09/2026 02/09/2026 17/09/2026 21/09/2026 23/09/2026 01/10/2026
24/08/2026 08/09/2026 09/09/2026 24/09/2026 28/09/2026 30/09/2026 08/10/2026
31/08/2026 15/09/2026 16/09/2026 01/10/2026 05/10/2026 07/10/2026 15/10/2026
07/09/2026 22/09/2026 23/09/2026 08/10/2026 12/10/2026 14/10/2026 22/10/2026
14/09/2026 29/09/2026 30/09/2026 15/10/2026 19/10/2026 21/10/2026 29/10/2026
21/09/2026 06/10/2026 07/10/2026 22/10/2026 26/10/2026 28/10/2026 05/11/2026
28/09/2026 13/10/2026 14/10/2026 29/10/2026 02/11/2026 04/11/2026 12/11/2026
05/10/2026 20/10/2026 21/10/2026 05/11/2026 09/11/2026 11/11/2026 19/11/2026
12/10/2026 27/10/2026 28/10/2026 12/11/2026 16/11/2026 18/11/2026 26/11/2026
19/10/2026 03/11/2026 04/11/2026 19/11/2026 23/11/2026 25/11/2026 03/12/2026
26/10/2026 10/11/2026 11/11/2026 26/11/2026 30/11/2026 02/12/2026 10/12/2026
02/11/2026 17/11/2026 18/11/2026 03/12/2026 07/12/2026 09/12/2026 17/12/2026
23/11/2026 08/12/2026 09/12/2026 24/12/2026 28/12/2026 30/12/2026 07/01/2027
30/11/2026 15/12/2026 16/12/2026 31/12/2026 04/01/2027 06/01/2027 14/01/2027
EMA/219234/2026 Page 19/46
第 20 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
07/12/2026 22/12/2026 23/12/2026 07/01/2027 11/01/2027 13/01/2027 21/01/2027
21/12/2026 05/01/2027 06/01/2027 21/01/2027 25/01/2027 27/01/2027 04/02/2027
28/12/2026 12/01/2027 13/01/2027 28/01/2027 01/02/2027 03/02/2027 11/02/2027
EMA/219234/2026 Page 20/46
第 21 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
2027
04/01/2027 19/01/2027 20/01/2027 04/02/2027 08/02/2027 10/02/2027 18/02/2027
11/01/2027 26/01/2027 27/01/2027 11/02/2027 15/02/2027 17/02/2027 25/02/2027
18/01/2027 02/02/2027 03/02/2027 18/02/2027 22/02/2027 24/02/2027 04/03/2027
25/01/2027 09/02/2027 10/02/2027 25/02/2027 01/03/2027 03/03/2027 11/03/2027
01/02/2027 16/02/2027 17/02/2027 04/03/2027 08/03/2027 10/03/2027 18/03/2027
08/02/2027 23/02/2027 24/02/2027 11/03/2027 15/03/2027 17/03/2027 25/03/2027
15/02/2027 02/03/2027 03/03/2027 18/03/2027 22/03/2027 24/03/2027 01/04/2027
22/02/2027 09/03/2027 10/03/2027 25/03/2027 29/03/2027 31/03/2027 08/04/2027
01/03/2027 16/03/2027 17/03/2027 01/04/2027 05/04/2027 07/04/2027 15/04/2027
08/03/2027 23/03/2027 24/03/2027 08/04/2027 12/04/2027 14/04/2027 22/04/2027
15/03/2027 30/03/2027 31/03/2027 15/04/2027 19/04/2027 21/04/2027 29/04/2027
22/03/2027 06/04/2027 07/04/2027 22/04/2027 26/04/2027 28/04/2027 06/05/2027
29/03/2027 13/04/2027 14/04/2027 29/04/2027 03/05/2027 05/05/2027 13/05/2027
05/04/2027 20/04/2027 21/04/2027 06/05/2027 10/05/2027 12/05/2027 20/05/2027
12/04/2027 27/04/2027 28/04/2027 13/05/2027 17/05/2027 19/05/2027 27/05/2027
19/04/2027 04/05/2027 05/05/2027 20/05/2027 24/05/2027 26/05/2027 03/06/2027
26/04/2027 11/05/2027 12/05/2027 27/05/2027 31/05/2027 02/06/2027 10/06/2027
03/05/2027 18/05/2027 19/05/2027 03/06/2027 07/06/2027 09/06/2027 17/06/2027
10/05/2027 25/05/2027 26/05/2027 10/06/2027 14/06/2027 16/06/2027 24/06/2027
17/05/2027 01/06/2027 02/06/2027 17/06/2027 21/06/2027 23/06/2027 01/07/2027
24/05/2027 08/06/2027 09/06/2027 24/06/2027 28/06/2027 30/06/2027 08/07/2027
31/05/2027 15/06/2027 16/06/2027 01/07/2027 05/07/2027 07/07/2027 15/07/2027
07/06/2027 22/06/2027 23/06/2027 08/07/2027 12/07/2027 14/07/2027 22/07/2027
EMA/219234/2026 Page 21/46
第 22 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
14/06/2027 29/06/2027 30/06/2027 15/07/2027 19/07/2027 21/07/2027 29/07/2027
21/06/2027 06/07/2027 07/07/2027 22/07/2027 26/07/2027 28/07/2027 05/08/2027
28/06/2027 13/07/2027 14/07/2027 29/07/2027 02/08/2027 04/08/2027 12/08/2027
05/07/2027 20/07/2027 21/07/2027 05/08/2027 09/08/2027 11/08/2027 19/08/2027
12/07/2027 27/07/2027 28/07/2027 12/08/2027 16/08/2027 18/08/2027 26/08/2027
19/07/2027 03/08/2027 04/08/2027 19/08/2027 23/08/2027 25/08/2027 02/09/2027
26/07/2027 10/08/2027 11/08/2027 26/08/2027 30/08/2027 01/09/2027 09/09/2027
02/08/2027 17/08/2027 18/08/2027 02/09/2027 06/09/2027 08/09/2027 16/09/2027
09/08/2027 24/08/2027 25/08/2027 09/09/2027 13/09/2027 15/09/2027 23/09/2027
16/08/2027 31/08/2027 01/09/2027 16/09/2027 20/09/2027 22/09/2027 30/09/2027
23/08/2027 07/09/2027 08/09/2027 23/09/2027 27/09/2027 29/09/2027 07/10/2027
30/08/2027 14/09/2027 15/09/2027 30/09/2027 04/10/2027 06/10/2027 14/10/2027
06/09/2027 21/09/2027 22/09/2027 07/10/2027 11/10/2027 13/10/2027 21/10/2027
13/09/2027 28/09/2027 29/09/2027 14/10/2027 18/10/2027 20/10/2027 28/10/2027
20/09/2027 05/10/2027 06/10/2027 21/10/2027 25/10/2027 27/10/2027 05/11/2027
27/09/2027 12/10/2027 13/10/2027 28/10/2027 01/11/2027 03/11/2027 11/11/2027
04/10/2027 19/10/2027 20/10/2027 04/11/2027 08/11/2027 10/11/2027 18/11/2027
11/10/2027 26/10/2027 27/10/2027 11/11/2027 15/11/2027 17/11/2027 25/11/2027
18/10/2027 02/11/2027 03/11/2027 18/11/2027 22/11/2027 24/11/2027 02/12/2027
25/10/2027 09/11/2027 10/11/2027 25/11/2027 29/11/2027 01/12/2027 09/12/2027
01/11/2027 16/11/2027 17/11/2027 02/12/2027 06/12/2027 08/12/2027 16/12/2027
08/11/2027 23/11/2027 24/11/2027 09/12/2027 13/12/2027 15/12/2027 23/12/2027
22/11/2027 07/12/2027 08/12/2027 23/12/2027 27/12/2027 29/12/2027 06/01/2028
29/11/2027 14/12/2027 15/12/2027 30/12/2027 03/01/2028 05/01/2028 13/01/2028
EMA/219234/2026 Page 22/46
第 23 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
06/12/2027 21/12/2027 22/12/2027 06/01/2028 10/01/2028 12/01/2028 20/01/2028
20/12/2027 04/01/2028 05/01/2028 20/01/2028 24/01/2028 26/01/2028 03/02/2028
27/12/2027 11/01/2028 12/01/2028 27/01/2028 31/01/2028 02/02/2028 10/02/2028
EMA/219234/2026 Page 23/46
第 24 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
2028
03/01/2028 18/01/2028 19/01/2028 03/02/2028 07/02/2028 09/02/2028 17/02/2028
10/01/2028 25/01/2028 26/01/2028 10/02/2028 14/02/2028 16/02/2028 24/02/2028
17/01/2028 01/02/2028 02/02/2028 17/02/2028 21/02/2028 23/02/2028 02/03/2028
24/01/2028 08/02/2028 09/02/2028 24/02/2028 28/02/2028 01/03/2028 09/03/2028
31/01/2028 15/02/2028 16/02/2028 02/03/2028 06/03/2028 08/03/2028 16/03/2028
07/02/2028 22/02/2028 23/02/2028 09/03/2028 13/03/2028 15/03/2028 23/03/2028
14/02/2028 29/02/2028 01/03/2028 16/03/2028 20/03/2028 22/03/2028 30/03/2028
21/02/2028 07/03/2028 08/03/2028 23/03/2028 27/03/2028 29/03/2028 06/04/2028
28/02/2028 14/03/2028 15/03/2028 30/03/2028 03/04/2028 05/04/2028 12/04/2028
06/03/2028 21/03/2028 22/03/2028 06/04/2028 10/04/2028 12/04/2028 20/04/2028
13/03/2028 28/03/2028 29/03/2028 13/04/2028 17/04/2028 19/04/2028 27/04/2028
20/03/2028 04/04/2028 05/04/2028 20/04/2028 24/04/2028 26/04/2028 04/05/2028
27/03/2028 11/04/2028 12/04/2028 27/04/2028 01/05/2028 03/05/2028 12/05/2028
03/04/2028 18/04/2028 19/04/2028 04/05/2028 08/05/2028 10/05/2028 18/05/2028
10/04/2028 25/04/2028 26/04/2028 11/05/2028 15/05/2028 17/05/2028 25/05/2028
17/04/2028 02/05/2028 03/05/2028 18/05/2028 22/05/2028 24/05/2028 01/06/2028
24/04/2028 09/05/2028 10/05/2028 25/05/2028 29/05/2028 31/05/2028 08/06/2028
01/05/2028 16/05/2028 17/05/2028 01/06/2028 05/06/2028 07/06/2028 15/06/2028
08/05/2028 23/05/2028 24/05/2028 08/06/2028 12/06/2028 14/06/2028 22/06/2028
15/05/2028 30/05/2028 31/05/2028 15/06/2028 19/06/2028 21/06/2028 29/06/2028
22/05/2028 06/06/2028 07/06/2028 22/06/2028 26/06/2028 28/06/2028 06/07/2028
29/05/2028 13/06/2028 14/06/2028 29/06/2028 03/07/2028 05/07/2028 13/07/2028
05/06/2028 20/06/2028 21/06/2028 06/07/2028 10/07/2028 12/07/2028 20/07/2028
EMA/219234/2026 Page 24/46
第 25 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of opinion
dossier comments revised AR (or adoption of list of
completed outstanding issues)
12/06/2028 27/06/2028 28/06/2028 13/07/2028 17/07/2028 19/07/2028 27/07/2028
19/06/2028 04/07/2028 05/07/2028 20/07/2028 24/07/2028 26/07/2028 03/08/2028
26/06/2028 11/07/2028 12/07/2028 27/07/2028 31/07/2028 02/08/2028 10/08/2028
03/07/2028 18/07/2028 19/07/2028 03/08/2028 07/08/2028 09/08/2028 17/08/2028
10/07/2028 25/07/2028 26/07/2028 10/08/2028 14/08/2028 16/08/2028 24/08/2028
17/07/2028 01/08/2028 02/08/2028 17/08/2028 21/08/2028 23/08/2028 31/08/2028
24/07/2028 08/08/2028 09/08/2028 24/08/2028 28/08/2028 30/08/2028 07/09/2028
31/07/2028 15/08/2028 16/08/2028 31/08/2028 04/09/2028 06/09/2028 14/09/2028
07/08/2028 22/08/2028 23/08/2028 07/09/2028 11/09/2028 13/09/2028 21/09/2028
14/08/2028 29/08/2028 30/08/2028 14/09/2028 18/09/2028 20/09/2028 28/09/2028
21/08/2028 05/09/2028 06/09/2028 21/09/2028 25/09/2028 27/09/2028 05/10/2028
28/08/2028 12/09/2028 13/09/2028 28/09/2028 02/10/2028 04/10/2028 12/10/2028
04/09/2028 19/09/2028 20/09/2028 05/10/2028 09/10/2028 11/10/2028 19/10/2028
11/09/2028 26/09/2028 27/09/2028 12/10/2028 16/10/2028 18/10/2028 26/10/2028
18/09/2028 03/10/2028 04/10/2028 19/10/2028 23/10/2028 25/10/2028 02/11/2028
25/09/2028 10/10/2028 11/10/2028 26/10/2028 30/10/2028 01/11/2028 09/11/2028
02/10/2028 17/10/2028 18/10/2028 02/11/2028 06/11/2028 08/11/2028 16/11/2028
09/10/2028 24/10/2028 25/10/2028 09/11/2028 13/11/2028 15/11/2028 23/11/2028
16/10/2028 31/10/2028 01/11/2028 16/11/2028 20/11/2028 22/11/2028 30/11/2028
23/10/2028 07/11/2028 08/11/2028 23/11/2028 27/11/2028 29/11/2028 07/12/2028
30/10/2028 14/11/2028 15/11/2028 30/11/2028 04/12/2028 06/12/2028 14/12/2028
06/11/2028 21/11/2028 22/11/2028 07/12/2028 11/12/2028 13/12/2028 21/12/2028
EMA/219234/2026 Page 25/46
第 26 页
Variations requiring assessment (reduced timetable with linguistic review – monthly
submissions) – 1st phase
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
dossier comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
2025
29/12/2025 13/01/2026 14/01/2026 29/01/2026 02/02/2026 04/02/2026 12/02/2026
2026
26/01/2026 10/02/2026 11/02/2026 26/02/2026 02/03/2026 04/03/2026 12/03/2026
N/A N/A N/A N/A N/A N/A N/A
02/03/2026 17/03/2026 18/03/2026 02/04/2026 06/04/2026 08/04/2026 16/04/2026
06/04/2026 21/04/2026 22/04/2026 07/05/2026 11/05/2026 13/05/2026 21/05/2026
04/05/2026 19/05/2026 20/05/2026 04/06/2026 08/06/2026 10/06/2026 18/06/2026
01/06/2026 16/06/2026 17/06/2026 02/07/2026 06/07/2026 08/07/2026 16/07/2026
27/07/2026 11/08/2026 12/08/2026 27/08/2026 31/08/2026 02/09/2026 10/09/2026
24/08/2026 08/09/2026 09/09/2026 24/09/2026 28/09/2026 30/09/2026 08/10/2026
21/09/2026 06/10/2026 07/10/2026 22/10/2026 26/10/2026 28/10/2026 05/11/2026
19/10/2026 03/11/2026 04/11/2026 19/11/2026 23/11/2026 25/11/2026 03/12/2026
N/A N/A N/A N/A N/A N/A N/A
08/12/2026 22/12/2026 23/12/2026 07/01/2027 11/01/2027 13/01/2027 21/01/2027
EMA/219234/2026 Page 26/46
第 27 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
dossier comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
2027
05/01/2027 19/01/2027 20/01/2027 04/02/2027 08/02/2027 10/02/2027 18/02/2027
02/02/2027 16/02/2027 17/02/2027 04/03/2027 08/03/2027 10/03/2027 18/03/2027
02/03/2027 16/03/2027 17/03/2027 01/04/2027 05/04/2027 07/04/2027 15/04/2027
06/04/2027 20/04/2027 21/04/2027 06/05/2027 10/05/2027 12/05/2027 20/05/2027
04/05/2027 18/05/2027 19/05/2027 03/06/2027 07/06/2027 09/06/2027 17/06/2027
01/06/2027 15/06/2027 16/06/2027 01/07/2027 05/07/2027 07/07/2027 15/07/2027
27/07/2027 10/08/2027 11/08/2027 26/08/2027 30/08/2027 01/09/2027 09/09/2027
24/08/2027 07/09/2027 08/09/2027 23/09/2027 27/09/2027 29/09/2027 07/10/2027
22/09/2027 06/10/2027 07/10/2027 22/10/2027 26/10/2027 28/10/2027 05/11/2027
19/10/2027 02/11/2027 03/11/2027 18/11/2027 22/11/2027 24/11/2027 02/12/2027
N/A N/A N/A N/A N/A N/A N/A
07/12/2027 21/12/2027 22/12/2027 06/01/2028 10/01/2028 12/01/2028 20/01/2028
04/01/2028 18/01/2028 19/01/2028 03/02/2028 07/02/2028 09/02/2028 17/02/2028
01/02/2028 15/02/2028 16/02/2028 02/03/2028 06/03/2028 08/03/2028 16/03/2028
28/02/2028 13/03/2028 14/03/2028 29/03/2028 31/03/2028 04/04/2028 12/04/2028
29/03/2028 12/04/2028 13/04/2028 28/04/2028 02/05/2028 04/05/2028 12/05/2028
02/05/2028 16/05/2028 17/05/2028 01/06/2028 05/06/2028 07/06/2028 15/06/2028
30/05/2028 13/06/2028 14/06/2028 29/06/2028 03/07/2028 05/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A N/A
25/07/2028 08/08/2028 09/08/2028 24/08/2028 28/08/2028 30/08/2028 07/09/2028
EMA/219234/2026 Page 27/46
第 28 页
Submission date Validation of Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
dossier comments revised AR opinion
completed (or adoption of
list of
outstanding
issues)
22/08/2028 05/09/2028 06/09/2028 21/09/2028 25/09/2028 27/09/2028 05/10/2028
26/09/2028 10/10/2028 11/10/2028 26/10/2028 30/10/2028 01/11/2028 09/11/2028
24/10/2028 07/11/2028 08/11/2028 23/11/2028 27/11/2028 29/11/2028 07/12/2028
EMA/219234/2026 Page 28/46
第 29 页
Response to the request for supplementary information for variations requiring
assessment (extended and standard timetables – monthly submission dates)6
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
2026
13/01/2026 14/01/2026 27/01/2026 02/02/2026 05/02/2026 12/02/2026
10/02/2026 11/02/2026 24/02/2026 02/03/2026 05/03/2026 12/03/2026
17/03/2026 18/03/2026 31/03/2026 07/04/2026 09/04/2026 16/04/2026
21/04/2026 22/04/2026 05/05/2026 11/05/2026 14/05/2026 21/05/2026
19/05/2026 20/05/2026 02/06/2026 08/06/2026 11/06/2026 18/06/2026
16/06/2026 17/06/2026 30/06/2026 06/07/2026 09/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A
11/08/2026 12/08/2026 25/08/2026 31/08/2026 03/09/2026 10/09/2026
08/09/2026 09/09/2026 22/09/2026 28/09/2026 01/10/2026 08/10/2026
06/10/2026 07/10/2026 20/10/2026 26/10/2026 29/10/2026 05/11/2026
03/11/2026 04/11/2026 17/11/2026 23/11/2026 26/11/2026 03/12/2026
18/12/2026 21/12/2026 05/01/2027 11/01/2027 14/01/2027 21/01/2027
2027
19/01/2027 20/01/2027 02/02/2027 08/02/2027 11/02/2027 18/02/2027
16/02/2027 17/02/2027 02/03/2027 08/03/2027 11/03/2027 18/03/2027
16/03/2027 17/03/2027 30/03/2027 05/04/2027 08/04/2027 15/04/2027
20/04/2027 21/04/2027 04/05/2027 10/05/2027 13/05/2027 20/05/2027
18/05/2027 19/05/2027 01/06/2027 07/06/2027 10/06/2027 17/06/2027
15/06/2027 16/06/2027 29/06/2027 05/07/2027 08/07/2027 15/07/2027
6 Applies also to responses for variations requiring assessment (reduced timetable with linguistic review)
EMA/219234/2026 Page 29/46
第 30 页
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
N/A N/A N/A N/A N/A N/A
10/08/2027 11/08/2027 24/08/2027 30/08/2027 02/09/2027 09/09/2027
07/09/2027 08/09/2027 21/09/2027 27/09/2027 30/09/2027 07/10/2027
06/10/2027 07/10/2027 20/10/2027 26/10/2027 29/10/2027 05/11/2027
02/11/2027 03/11/2027 16/11/2027 22/11/2027 25/11/2027 02/12/2027
17/12/2027 20/12/2027 04/01/2028 10/01/2028 13/01/2028 20/01/2028
2028
18/01/2028 19/01/2028 01/02/2028 07/02/2028 10/02/2028 17/02/2028
15/02/2028 16/02/2028 29/02/2028 06/03/2028 09/03/2028 16/03/2028
13/03/2028 14/03/2028 27/03/2028 31/03/2028 05/04/2028 12/04/2028
11/04/2028 12/04/2028 26/04/2028 02/05/2028 05/05/2028 12/05/2028
16/05/2028 17/05/2028 30/05/2028 05/06/2028 08/06/2028 15/06/2028
13/06/2028 14/06/2028 27/06/2028 03/07/2028 06/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A
08/08/2028 09/08/2028 22/08/2028 28/08/2028 31/08/2028 07/09/2028
05/09/2028 06/09/2028 19/09/2028 25/09/2028 28/09/2028 05/10/2028
10/10/2028 11/10/2028 24/10/2028 30/10/2028 02/11/2028 09/11/2028
07/11/2028 08/11/2028 21/11/2028 27/11/2028 30/11/2028 07/12/2028
EMA/219234/2026 Page 30/46
第 31 页
Response to the request for supplementary information for variations requiring
assessment (reduced timetable – weekly submission dates)
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
2026
06/01/2026 07/01/2026 20/01/2026 26/01/2026 29/01/2026 05/02/2026
13/01/2026 14/01/2026 27/01/2026 02/02/2026 05/02/2026 12/02/2026
20/01/2026 21/01/2026 03/02/2026 09/02/2026 12/02/2026 19/02/2026
27/01/2026 28/01/2026 10/02/2026 16/02/2026 19/02/2026 26/02/2026
03/02/2026 04/02/2026 17/02/2026 23/02/2026 26/02/2026 05/03/2026
10/02/2026 11/02/2026 24/02/2026 02/03/2026 05/03/2026 12/03/2026
17/02/2026 18/02/2026 03/03/2026 09/03/2026 12/03/2026 19/03/2026
24/02/2026 25/02/2026 10/03/2026 16/03/2026 19/03/2026 26/03/2026
03/03/2026 04/03/2026 17/03/2026 23/03/2026 26/03/2026 02/04/2026
10/03/2026 11/03/2026 24/03/2026 30/03/2026 02/04/2026 09/04/2026
17/03/2026 18/03/2026 31/03/2026 06/04/2026 09/04/2026 16/04/2026
24/03/2026 25/03/2026 07/04/2026 13/04/2026 16/04/2026 23/04/2026
31/03/2026 01/04/2026 14/04/2026 20/04/2026 23/04/2026 30/04/2026
07/04/2026 08/04/2026 21/04/2026 27/04/2026 30/04/2026 07/05/2026
14/04/2026 15/04/2026 28/04/2026 04/05/2026 07/05/2026 14/05/2026
21/04/2026 22/04/2026 05/05/2026 11/05/2026 14/05/2026 21/05/2026
28/04/2026 29/04/2026 12/05/2026 18/05/2026 21/05/2026 28/05/2026
05/05/2026 06/05/2026 19/05/2026 25/05/2026 28/05/2026 04/06/2026
12/05/2026 13/05/2026 26/05/2026 01/06/2026 04/06/2026 11/06/2026
19/05/2026 20/05/2026 02/06/2026 08/06/2026 11/06/2026 18/06/2026
26/05/2026 27/05/2026 09/06/2026 15/06/2026 18/06/2026 25/06/2026
02/06/2026 03/06/2026 16/06/2026 22/06/2026 25/06/2026 02/07/2026
EMA/219234/2026 Page 31/46
第 32 页
09/06/2026 10/06/2026 23/06/2026 29/06/2026 02/07/2026 09/07/2026
16/06/2026 17/06/2026 30/06/2026 06/07/2026 09/07/2026 16/07/2026
23/06/2026 24/06/2026 07/07/2026 13/07/2026 16/07/2026 23/07/2026
30/06/2026 01/07/2026 14/07/2026 20/07/2026 23/07/2026 30/07/2026
07/07/2026 08/07/2026 21/07/2026 27/07/2026 30/07/2026 06/08/2026
11/08/2026 12/08/2026 25/08/2026 31/08/2026 03/09/2026 10/09/2026
18/08/2026 19/08/2026 01/09/2026 07/09/2026 10/09/2026 17/09/2026
25/08/2026 26/08/2026 08/09/2026 14/09/2026 17/09/2026 24/09/2026
01/09/2026 02/09/2026 15/09/2026 21/09/2026 24/09/2026 01/10/2026
08/09/2026 09/09/2026 22/09/2026 28/09/2026 01/10/2026 08/10/2026
15/09/2026 16/09/2026 29/09/2026 05/10/2026 08/10/2026 15/10/2026
22/09/2026 23/09/2026 06/10/2026 12/10/2026 15/10/2026 22/10/2026
29/09/2026 30/09/2026 13/10/2026 19/10/2026 22/10/2026 29/10/2026
06/10/2026 07/10/2026 20/10/2026 26/10/2026 29/10/2026 05/11/2026
13/10/2026 14/10/2026 27/10/2026 02/11/2026 05/11/2026 12/11/2026
20/10/2026 21/10/2026 03/11/2026 09/11/2026 12/11/2026 19/11/2026
27/10/2026 28/10/2026 10/11/2026 16/11/2026 19/11/2026 26/11/2026
03/11/2026 04/11/2026 17/11/2026 23/11/2026 26/11/2026 03/12/2026
10/11/2026 11/11/2026 24/11/2026 30/11/2026 03/12/2026 10/12/2026
17/11/2026 18/11/2026 01/12/2026 07/12/2026 10/12/2026 17/12/2026
08/12/2026 09/12/2026 22/12/2026 28/12/2026 31/12/2026 07/01/2027
15/12/2026 16/12/2026 29/12/2026 04/01/2027 07/01/2027 14/01/2027
22/12/2026 23/12/2026 05/01/2027 11/01/2027 14/01/2027 21/01/2027
29/12/2026 30/12/2026 12/01/2027 18/01/2027 21/01/2027 28/01/2027
EMA/219234/2026 Page 32/46
第 33 页
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
2027
05/01/2027 06/01/2027 19/01/2027 25/01/2027 28/01/2027 04/02/2027
12/01/2027 13/01/2027 26/01/2027 01/02/2027 04/02/2027 11/02/2027
19/01/2027 20/01/2027 02/02/2027 08/02/2027 11/02/2027 18/02/2027
26/01/2027 27/01/2027 09/02/2027 15/02/2027 18/02/2027 25/02/2027
02/02/2027 03/02/2027 16/02/2027 22/02/2027 25/02/2027 04/03/2027
09/02/2027 10/02/2027 23/02/2027 01/03/2027 04/03/2027 11/03/2027
16/02/2027 17/02/2027 02/03/2027 08/03/2027 11/03/2027 18/03/2027
23/02/2027 24/02/2027 09/03/2027 15/03/2027 18/03/2027 25/03/2027
02/03/2027 03/03/2027 16/03/2027 22/03/2027 25/03/2027 01/04/2027
09/03/2027 10/03/2027 23/03/2027 29/03/2027 01/04/2027 08/04/2027
16/03/2027 17/03/2027 30/03/2027 05/04/2027 08/04/2027 15/04/2027
23/03/2027 24/03/2027 06/04/2027 12/04/2027 15/04/2027 22/04/2027
30/03/2027 31/03/2027 13/04/2027 19/04/2027 22/04/2027 29/04/2027
06/04/2027 07/04/2027 20/04/2027 26/04/2027 29/04/2027 06/05/2027
13/04/2027 14/04/2027 27/04/2027 03/05/2027 06/05/2027 13/05/2027
20/04/2027 21/04/2027 04/05/2027 10/05/2027 13/05/2027 20/05/2027
27/04/2027 28/04/2027 11/05/2027 17/05/2027 20/05/2027 27/05/2027
04/05/2027 05/05/2027 18/05/2027 24/05/2027 27/05/2027 03/06/2027
11/05/2027 12/05/2027 25/05/2027 31/05/2027 03/06/2027 10/06/2027
18/05/2027 19/05/2027 01/06/2027 07/06/2027 10/06/2027 17/06/2027
25/05/2027 26/05/2027 08/06/2027 14/06/2027 17/06/2027 24/06/2027
01/06/2027 02/06/2027 15/06/2027 21/06/2027 24/06/2027 01/07/2027
08/06/2027 09/06/2027 22/06/2027 28/06/2027 01/07/2027 08/07/2027
15/06/2027 16/06/2027 29/06/2027 05/07/2027 08/07/2027 15/07/2027
22/06/2027 23/06/2027 06/07/2027 12/07/2027 15/07/2027 22/07/2027
29/06/2027 30/06/2027 13/07/2027 19/07/2027 22/07/2027 29/07/2027
06/07/2027 07/07/2027 20/07/2027 26/07/2027 29/07/2027 05/08/2027
EMA/219234/2026 Page 33/46
第 34 页
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
13/07/2027 14/07/2027 27/07/2027 02/08/2027 05/08/2027 12/08/2027
20/07/2027 21/07/2027 03/08/2027 09/08/2027 12/08/2027 19/08/2027
27/07/2027 28/07/2027 10/08/2027 16/08/2027 19/08/2027 26/08/2027
03/08/2027 04/08/2027 17/08/2027 23/08/2027 26/08/2027 02/09/2027
10/08/2027 11/08/2027 24/08/2027 30/08/2027 02/09/2027 09/09/2027
17/08/2027 18/08/2027 31/08/2027 06/09/2027 09/09/2027 16/09/2027
24/08/2027 25/08/2027 07/09/2027 13/09/2027 16/09/2027 23/09/2027
31/08/2027 01/09/2027 14/09/2027 20/09/2027 23/09/2027 30/09/2027
07/09/2027 08/09/2027 21/09/2027 27/09/2027 30/09/2027 07/10/2027
14/09/2027 15/09/2027 28/09/2027 04/10/2027 07/10/2027 14/10/2027
21/09/2027 22/09/2027 05/10/2027 11/10/2027 14/10/2027 21/10/2027
28/09/2027 29/09/2027 12/10/2027 18/10/2027 21/10/2027 28/10/2027
05/10/2027 06/10/2027 19/10/2027 25/10/2027 28/10/2027 05/11/2027
12/10/2027 13/10/2027 26/10/2027 01/11/2027 04/11/2027 11/11/2027
19/10/2027 20/10/2027 02/11/2027 08/11/2027 11/11/2027 18/11/2027
26/10/2027 27/10/2027 09/11/2027 15/11/2027 18/11/2027 25/11/2027
02/11/2027 03/11/2027 16/11/2027 22/11/2027 25/11/2027 02/12/2027
09/11/2027 10/11/2027 23/11/2027 29/11/2027 02/12/2027 09/12/2027
16/11/2027 17/11/2027 30/11/2027 06/12/2027 09/12/2027 16/12/2027
23/11/2027 24/11/2027 07/12/2027 13/12/2027 16/12/2027 23/12/2027
07/12/2027 08/12/2027 21/12/2027 27/12/2027 30/12/2027 06/01/2028
14/12/2027 15/12/2027 28/12/2027 03/01/2028 06/01/2028 13/01/2028
21/12/2027 22/12/2027 04/01/2028 10/01/2028 13/01/2028 20/01/2028
EMA/219234/2026 Page 34/46
第 35 页
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
2028
04/01/2028 05/01/2028 18/01/2028 24/01/2028 27/01/2028 03/02/2028
11/01/2028 12/01/2028 25/01/2028 31/01/2028 03/02/2028 10/02/2028
18/01/2028 19/01/2028 01/02/2028 07/02/2028 10/02/2028 17/02/2028
25/01/2028 26/01/2028 08/02/2028 14/02/2028 17/02/2028 24/02/2028
01/02/2028 02/02/2028 15/02/2028 21/02/2028 24/02/2028 02/03/2028
08/02/2028 09/02/2028 22/02/2028 28/02/2028 02/03/2028 09/03/2028
15/02/2028 16/02/2028 29/02/2028 06/03/2028 09/03/2028 16/03/2028
22/02/2028 23/02/2028 07/03/2028 13/03/2028 16/03/2028 23/03/2028
29/02/2028 01/03/2028 14/03/2028 20/03/2028 23/03/2028 30/03/2028
07/03/2028 08/03/2028 21/03/2028 27/03/2028 30/03/2028 06/04/2028
14/03/2028 15/03/2028 28/03/2028 03/04/2028 06/04/2028 12/04/2028
21/03/2028 22/03/2028 04/04/2028 10/04/2028 13/04/2028 20/04/2028
28/03/2028 29/03/2028 11/04/2028 17/04/2028 20/04/2028 27/04/2028
04/04/2028 05/04/2028 18/04/2028 24/04/2028 27/04/2028 04/05/2028
11/04/2028 12/04/2028 25/04/2028 01/05/2028 04/05/2028 12/05/2028
18/04/2028 19/04/2028 02/05/2028 08/05/2028 11/05/2028 18/05/2028
25/04/2028 26/04/2028 09/05/2028 15/05/2028 18/05/2028 25/05/2028
02/05/2028 03/05/2028 16/05/2028 22/05/2028 25/05/2028 01/06/2028
09/05/2028 10/05/2028 23/05/2028 29/05/2028 01/06/2028 08/06/2028
16/05/2028 17/05/2028 30/05/2028 05/06/2028 08/06/2028 15/06/2028
23/05/2028 24/05/2028 06/06/2028 12/06/2028 15/06/2028 22/06/2028
30/05/2028 31/05/2028 13/06/2028 19/06/2028 22/06/2028 29/06/2028
06/06/2028 07/06/2028 20/06/2028 26/06/2028 29/06/2028 06/07/2028
13/06/2028 14/06/2028 27/06/2028 03/07/2028 06/07/2028 13/07/2028
20/06/2028 21/06/2028 04/07/2028 10/07/2028 13/07/2028 20/07/2028
27/06/2028 28/06/2028 11/07/2028 17/07/2028 20/07/2028 27/07/2028
04/07/2028 05/07/2028 18/07/2028 24/07/2028 27/07/2028 03/08/2028
EMA/219234/2026 Page 35/46
第 36 页
Submission date Start Rapporteurs’ AR CVMP Rapporteur’s Adoption of
comments revised AR opinion
11/07/2028 12/07/2028 25/07/2028 31/07/2028 03/08/2028 10/08/2028
18/07/2028 19/07/2028 01/08/2028 07/08/2028 10/08/2028 17/08/2028
25/07/2028 26/07/2028 08/08/2028 14/08/2028 17/08/2028 24/08/2028
01/08/2028 02/08/2028 15/08/2028 21/08/2028 24/08/2028 31/08/2028
08/08/2028 09/08/2028 22/08/2028 28/08/2028 31/08/2028 07/09/2028
15/08/2028 16/08/2028 29/08/2028 04/09/2028 07/09/2028 14/09/2028
22/08/2028 23/08/2028 05/09/2028 11/09/2028 14/09/2028 21/09/2028
29/08/2028 30/08/2028 12/09/2028 18/09/2028 21/09/2028 28/09/2028
05/09/2028 06/09/2028 19/09/2028 25/09/2028 28/09/2028 05/10/2028
12/09/2028 13/09/2028 26/09/2028 02/10/2028 05/10/2028 12/10/2028
19/09/2028 20/09/2028 03/10/2028 09/10/2028 12/10/2028 19/10/2028
26/09/2028 27/09/2028 10/10/2028 16/10/2028 19/10/2028 26/10/2028
03/10/2028 04/10/2028 17/10/2028 23/10/2028 26/10/2028 02/11/2028
10/10/2028 11/10/2028 24/10/2028 30/10/2028 02/11/2028 09/11/2028
17/10/2028 18/10/2028 31/10/2028 06/11/2028 09/11/2028 16/11/2028
24/10/2028 25/10/2028 07/11/2028 13/11/2028 16/11/2028 23/11/2028
31/10/2028 01/11/2028 14/11/2028 20/11/2028 23/11/2028 30/11/2028
07/11/2028 08/11/2028 21/11/2028 27/11/2028 30/11/2028 07/12/2028
14/11/2028 15/11/2028 28/11/2028 04/12/2028 07/12/2028 14/12/2028
21/11/2028 22/11/2028 05/12/2028 11/12/2028 14/12/2028 21/12/2028
EMA/219234/2026 Page 36/46
第 37 页
VAMF/vPTMF – 1st phase
Submission date Validation of Start (day 1) Rapporteurs’ AR Co-rapporteur’s CVMP comments Rapporteurs’ Adoption of
dossier comments revised AR certificate (or
completed adoption of list
of questions)
(day 90)
2025
25/08/2025 08/09/2025 09/09/2025 20/10/2025 27/10/2025 10/11/2025 17/11/2025 04/12/2025
06/10/2025 20/10/2025 21/10/2025 01/12/2025 08/12/2025 22/12/2025 29/12/2025 15/01/2026
03/11/2025 17/11/2025 18/11/2025 29/12/2025 05/01/2026 19/01/2026 26/01/2026 12/02/2026
01/12/2025 15/12/2025 16/12/2025 26/01/2026 02/02/2026 16/02/2026 23/02/2026 12/03/2026
2026
05/01/2026 19/01/2026 20/01/2026 02/03/2026 09/03/2026 23/03/2026 30/03/2026 16/04/2026
09/02/2026 23/02/2026 24/02/2026 06/04/2026 13/04/2026 27/04/2026 04/05/2026 21/05/2026
09/03/2026 23/03/2026 24/03/2026 04/05/2026 11/05/2026 25/05/2026 01/06/2026 18/06/2026
06/04/2026 20/04/2026 21/04/2026 01/06/2026 08/06/2026 22/06/2026 29/06/2026 16/07/2026
01/06/2026 15/06/2026 16/06/2026 27/07/2026 03/08/2026 17/08/2026 24/08/2026 10/09/2026
29/06/2026 13/07/2026 14/07/2026 24/08/2026 31/08/2026 14/09/2026 21/09/2026 08/10/2026
27/07/2026 10/08/2026 11/08/2026 21/09/2026 28/09/2026 12/10/2026 19/10/2026 05/11/2026
24/08/2026 07/09/2026 08/09/2026 19/10/2026 26/10/2026 09/11/2026 16/11/2026 03/12/2026
N/A N/A N/A N/A N/A N/A N/A N/A
12/10/2026 26/10/2026 27/10/2026 07/12/2026 14/12/2026 21/12/2026 11/01/2027 21/01/2027
09/11/2026 23/11/2026 24/11/2026 04/01/2027 11/01/2027 25/01/2027 08/02/2027 18/02/2027
07/12/2026 21/12/2026 22/12/2026 01/02/2027 08/02/2027 22/02/2027 08/03/2027 18/03/2027
EMA/219234/2026 Page 37/46
第 38 页
Submission date Validation of Start (day 1) Rapporteurs’ AR Co-rapporteur’s CVMP comments Rapporteurs’ Adoption of
dossier comments revised AR certificate (or
completed adoption of list
of questions)
(day 90)
2027
04/01/2027 18/01/2027 19/01/2027 01/03/2027 08/03/2027 22/03/2027 05/04/2027 15/04/2027
08/02/2027 22/02/2027 23/02/2027 05/04/2027 12/04/2027 26/04/2027 10/05/2027 20/05/2027
08/03/2027 22/03/2027 23/03/2027 03/05/2027 10/05/2027 24/05/2027 07/06/2027 17/06/2027
05/04/2027 19/04/2027 20/04/2027 31/05/2027 07/06/2027 21/06/2027 05/07/2027 15/07/2027
31/05/2027 14/06/2027 15/06/2027 26/07/2027 02/08/2027 16/08/2027 27/08/2027 09/09/2027
28/06/2027 12/07/2027 13/07/2027 23/08/2027 30/08/2027 13/09/2027 27/09/2027 07/10/2027
26/07/2027 09/08/2027 10/08/2027 21/09/2027 28/09/2027 12/10/2027 25/10/2027 05/11/2027
23/08/2027 06/09/2027 07/09/2027 18/10/2027 25/10/2027 08/11/2027 22/11/2027 02/12/2027
N/A N/A N/A N/A N/A N/A N/A N/A
11/10/2027 25/10/2027 26/10/2027 06/12/2027 13/12/2027 20/12/2027 10/01/2028 20/01/2028
08/11/2027 22/11/2027 23/11/2027 03/01/2028 10/01/2028 24/01/2028 07/02/2028 17/02/2028
06/12/2027 20/12/2027 21/12/2027 31/01/2028 07/02/2028 21/02/2028 06/03/2028 16/03/2028
2028
03/01/2028 17/01/2028 18/01/2028 28/02/2028 06/03/2028 20/03/2028 03/04/2028 12/04/2028
31/01/2028 14/02/2028 15/02/2028 28/03/2028 04/04/2028 18/04/2028 28/04/2028 12/05/2028
06/03/2028 20/03/2028 21/03/2028 01/05/2028 08/05/2028 22/05/2028 05/06/2028 15/06/2028
03/04/2028 17/04/2028 18/04/2028 29/05/2028 05/06/2028 19/06/2028 03/07/2028 13/07/2028
29/05/2028 12/06/2028 13/06/2028 24/07/2028 31/07/2028 14/08/2028 28/08/2028 07/09/2028
26/06/2028 10/07/2028 11/07/2028 21/08/2028 28/08/2028 11/09/2028 26/09/2028 05/10/2028
31/07/2028 14/08/2028 15/08/2028 25/09/2028 02/10/2028 16/10/2028 27/10/2028 09/11/2028
28/08/2028 11/09/2028 12/09/2028 23/10/2028 30/10/2028 13/11/2028 27/11/2028 07/12/2028
EMA/219234/2026 Page 38/46
第 39 页
VAMF/vPTMF – 2nd phase
Submission date Start Rapporteurs’ AR Co-rapporteur’s CVMP comments Rapporteurs’ Adoption of
comments revised AR certificate
2025
06/10/2025 07/10/2025 27/10/2025 03/11/2025 10/11/2025 17/11/2025 04/12/2025
17/11/2025 18/11/2025 08/12/2025 15/12/2025 22/12/2025 29/12/2025 15/01/2026
15/12/2025 16/12/2025 05/01/2026 12/01/2026 19/01/2026 26/01/2026 12/02/2026
2026
12/01/2026 13/01/2026 02/02/2026 09/02/2026 16/02/2026 23/02/2026 12/03/2026
16/02/2026 17/02/2026 09/03/2026 16/03/2026 23/03/2026 30/03/2026 16/04/2026
23/03/2026 24/03/2026 13/04/2026 20/04/2026 27/04/2026 04/05/2026 21/05/2026
20/04/2026 21/04/2026 11/05/2026 18/05/2026 25/05/2026 01/06/2026 18/06/2026
18/05/2026 19/05/2026 08/06/2026 15/06/2026 22/06/2026 29/06/2026 16/07/2026
N/A N/A N/A N/A N/A N/A N/A
13/07/2026 14/07/2026 03/08/2026 10/08/2026 17/08/2026 24/08/2026 10/09/2026
10/08/2026 11/08/2026 31/08/2026 07/09/2026 14/09/2026 21/09/2026 08/10/2026
07/09/2026 08/09/2026 28/09/2026 05/10/2026 12/10/2026 19/10/2026 05/11/2026
05/10/2026 06/10/2026 26/10/2026 02/11/2026 09/11/2026 16/11/2026 03/12/2026
23/11/2026 24/11/2026 11/12/2026 18/12/2026 21/12/2026 11/01/2027 21/01/2027
17/12/2026 18/12/2026 08/01/2027 15/01/2027 22/01/2027 08/02/2027 18/02/2027
2027
18/01/2027 19/01/2027 05/02/2027 12/02/2027 19/02/2027 08/03/2027 18/03/2027
15/02/2027 16/02/2027 05/03/2027 19/03/2027 25/03/2027 05/04/2027 15/04/2027
22/03/2027 23/03/2027 09/04/2027 16/04/2027 23/04/2027 10/05/2027 20/05/2027
19/04/2027 20/04/2027 07/05/2027 14/05/2027 21/05/2027 07/06/2027 17/06/2027
17/05/2027 18/05/2027 04/06/2027 11/06/2027 18/06/2027 05/07/2027 15/07/2027
12/07/2027 13/07/2027 30/07/2027 06/08/2027 17/08/2027 27/08/2027 09/09/2027
09/08/2027 10/08/2027 27/08/2027 03/09/2027 13/09/2027 27/09/2027 07/10/2027
EMA/219234/2026 Page 39/46
第 40 页
Submission date Start Rapporteurs’ AR Co-rapporteur’s CVMP comments Rapporteurs’ Adoption of
comments revised AR certificate
06/09/2027 07/09/2027 27/09/2027 04/10/2027 11/10/2027 25/10/2027 05/11/2027
04/10/2027 05/10/2027 22/10/2027 29/10/2027 09/11/2027 22/11/2027 02/12/2027
22/11/2027 23/11/2027 10/12/2027 17/12/2027 21/12/2027 10/01/2028 20/01/2028
20/12/2027 21/12/2027 07/01/2028 14/01/2028 24/01/2028 07/02/2028 17/02/2028
2028
17/01/2028 18/01/2028 04/02/2028 11/02/2028 21/02/2028 06/03/2028 16/03/2028
14/02/2028 15/02/2028 02/03/2028 09/03/2028 20/03/2028 03/04/2028 12/04/2028
13/03/2028 14/03/2028 31/03/2028 07/04/2028 17/04/2028 28/04/2028 12/05/2028
17/04/2028 18/04/2028 05/05/2028 12/05/2028 26/05/2028 05/06/2028 15/06/2028
15/05/2028 16/05/2028 02/06/2028 09/06/2028 19/06/2028 03/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A N/A
10/07/2028 11/07/2028 28/07/2028 04/08/2028 15/08/2028 28/08/2028 07/09/2028
07/08/2028 08/08/2028 25/08/2028 06/09/2028 13/09/2028 26/09/2028 05/10/2028
11/09/2028 12/09/2028 20/09/2028 06/10/2028 16/10/2028 27/10/2028 09/11/2028
09/10/2028 10/10/2028 27/10/2028 03/11/2028 13/11/2028 27/11/2028 07/12/2028
EMA/219234/2026 Page 40/46
第 41 页
Centralised (initial applications) – 1st phase (accelerated assessment)
Deadline for Validation of Start (day 1) Rapporteur’s Co- Comments Rapporteur’s Draft List of Adoption of
submission7 dossier AR rapporteur’s from CVMP meeting Questions list of
completed comments members (teleconference) questions
including peer (day 120)
review
2026
N/A N/A N/A N/A N/A N/A N/A N/A N/A
06/02/2026 19/02/2026 20/02/2026 06/04/2026 13/04/2026 27/04/2026 13/05/2026 15/05/2026 21/05/2026
06/03/2026 19/03/2026 20/03/2026 04/05/2026 11/05/2026 25/05/2026 10/06/2026 12/06/2026 18/06/2026
03/04/2026 16/04/2026 17/04/2026 01/06/2026 08/06/2026 22/06/2026 08/07/2026 10/07/2026 16/07/2026
29/05/2026 11/06/2026 12/06/2026 27/07/2026 03/08/2026 17/08/2026 02/09/2026 04/09/2026 10/09/2026
26/06/2026 09/07/2026 10/07/2026 24/08/2026 31/08/2026 14/09/2026 30/09/2026 02/10/2026 08/10/2026
24/07/2026 06/08/2026 07/08/2026 21/09/2026 28/09/2026 12/10/2026 28/10/2026 30/10/2026 05/11/2026
21/08/2026 03/09/2026 04/09/2026 19/10/2026 26/10/2026 09/11/2026 25/11/2026 27/11/2026 03/12/2026
N/A N/A N/A N/A N/A N/A N/A N/A N/A
09/10/2026 23/10/2026 26/10/2026 07/12/2026 14/12/2026 28/12/2026 13/01/2027 15/01/2027 21/01/2027
06/11/2026 20/11/2026 23/11/2026 04/01/2027 11/01/2027 25/01/2027 10/02/2027 12/02/2027 18/02/2027
04/12/2026 18/12/2026 21/12/2026 01/02/2027 08/02/2027 22/02/2027 10/03/2027 12/03/2027 18/03/2027
7 The Agency strongly recommends submitting the application up to 7 days before the published submission deadline.
EMA/219234/2026 Page 41/46
第 42 页
Deadline for Validation of Start (day 1) Rapporteur’s Co- Comments Rapporteur’s Draft List of Adoption of
submission8 dossier AR rapporteur’s from CVMP meeting Questions list of
completed comments members (teleconference) questions
including peer (day 120)
review
2027
04/01/2027 15/01/2027 18/01/2027 01/03/2027 08/03/2027 22/03/2027 07/04/2027 09/04/2027 15/04/2027
05/02/2027 19/02/2027 22/02/2027 05/04/2027 12/04/2027 26/04/2027 12/05/2027 14/05/2027 20/05/2027
05/03/2027 19/03/2027 22/03/2027 03/05/2027 10/05/2027 24/05/2027 09/06/2027 11/06/2027 17/06/2027
02/04/2027 16/04/2027 19/04/2027 31/05/2027 07/06/2027 21/06/2027 07/07/2027 09/07/2027 15/07/2027
28/05/2027 11/06/2027 14/06/2027 26/07/2027 02/08/2027 16/08/2027 01/09/2027 03/09/2027 09/09/2027
25/06/2027 09/07/2027 12/07/2027 23/08/2027 30/08/2027 13/09/2027 29/09/2027 01/10/2027 07/10/2027
23/07/2027 06/08/2027 09/08/2027 21/09/2027 28/09/2027 12/10/2027 28/10/2027 29/10/2027 05/11/2027
20/08/2027 03/09/2027 06/09/2027 18/10/2027 25/10/2027 08/11/2027 24/11/2027 26/11/2027 02/12/2027
N/A N/A N/A N/A N/A N/A N/A N/A N/A
08/10/2027 22/10/2027 25/10/2027 06/12/2027 13/12/2027 27/12/2027 12/01/2028 14/01/2028 20/01/2028
05/11/2027 19/11/2027 22/11/2027 03/01/2028 10/01/2028 24/01/2028 09/02/2028 11/02/2028 17/02/2028
03/12/2027 17/12/2027 20/12/2027 31/01/2028 07/02/2028 21/02/2028 08/03/2028 10/03/2028 16/03/2028
30/12/2027 14/01/2028 17/01/2028 28/02/2028 03/03/2028 20/03/2028 04/04/2028 06/04/2028 12/04/2028
2028
28/01/2028 11/02/2028 14/02/2028 28/03/2028 04/04/2028 18/04/2028 04/05/2028 05/05/2028 12/05/2028
03/03/2028 17/03/2028 20/03/2028 02/05/2028 08/05/2028 22/05/2028 07/06/2028 09/06/2028 15/06/2028
31/03/2028 14/04/2028 17/04/2028 29/05/2028 05/06/2028 19/06/2028 05/07/2028 07/07/2028 13/07/2028
26/05/2028 09/06/2028 12/06/2028 24/07/2028 31/07/2028 14/08/2028 30/08/2028 01/09/2028 07/09/2028
23/06/2028 07/07/2028 10/07/2028 21/08/2028 28/08/2028 11/09/2028 27/09/2028 29/09/2028 05/10/2028
28/07/2028 11/08/2028 14/08/2028 25/09/2028 02/10/2028 16/10/2028 01/11/2028 03/11/2028 09/11/2028
25/08/2028 08/09/2028 11/09/2028 23/10/2028 30/10/2028 13/11/2028 29/11/2028 01/12/2028 07/12/2028
8 The Agency strongly recommends submitting the application up to 7 days before the published submission deadline.
EMA/219234/2026 Page 42/46
第 43 页
Responses to the list of questions (LoQ) – 2nd phase (accelerated assessment)
Submission of Clock restart QRD comments Joint AR on CVMP & peer Rapporteur’s Adoption of list of
response to LoQ response to LoQ review comments meeting/ outstanding issues
teleconference (if and decision on
necessary) oral explanation
2025
16/12/2025 17/12/2025 25/12/2025 29/12/2025 05/01/2026 07/01/2026 15/01/2026
2026
13/01/2026 14/01/2026 22/01/2026 26/01/2026 02/02/2026 04/02/2026 12/02/2026
10/02/2026 11/02/2026 19/02/2026 23/02/2026 02/03/2026 04/03/2026 12/03/2026
17/03/2026 18/03/2026 26/03/2026 30/03/2026 06/04/2026 08/04/2026 16/04/2026
21/04/2026 22/04/2026 30/04/2026 04/05/2026 11/05/2026 13/05/2026 21/05/2026
19/05/2026 20/05/2026 28/05/2026 01/06/2026 08/06/2026 10/06/2026 18/06/2026
16/06/2026 17/06/2026 25/06/2026 29/06/2026 06/07/2026 08/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A N/A
11/08/2026 12/08/2026 20/08/2026 24/08/2026 31/08/2026 02/09/2026 10/09/2026
08/09/2026 09/09/2026 17/09/2026 21/09/2026 28/09/2026 30/09/2026 08/10/2026
06/10/2026 07/10/2026 15/10/2026 19/10/2026 26/10/2026 28/10/2026 05/11/2026
03/11/2026 04/11/2026 12/11/2026 16/11/2026 23/11/2026 25/11/2026 03/12/2026
18/12/2026 21/12/2026 31/12/2026 04/01/2027 11/01/2027 13/01/2027 21/01/2027
2027
19/01/2027 20/01/2027 28/01/2027 01/02/2027 08/02/2027 10/02/2027 18/02/2027
16/02/2027 17/02/2027 25/02/2027 01/03/2027 08/03/2027 10/03/2027 18/03/2027
EMA/219234/2026 Page 43/46
第 44 页
Submission of Clock restart (day QRD comments Joint AR on CVMP & peer Rapporteur’s Adoption of list of
response to LoQ 121) response to LoQ review comments meeting/ outstanding issues
teleconference (if and decision on
necessary) oral explanation
(day 180)
16/03/2027 17/03/2027 25/03/2027 29/03/2027 05/04/2027 07/04/2027 15/04/2027
20/04/2027 21/04/2027 29/04/2027 03/05/2027 10/05/2027 12/05/2027 20/05/2027
18/05/2027 19/05/2027 27/05/2027 31/05/2027 07/06/2027 09/06/2027 17/06/2027
15/06/2027 16/06/2027 24/06/2027 28/06/2027 05/07/2027 07/07/2027 15/07/2027
Ν/Α Ν/Α Ν/Α Ν/Α Ν/Α Ν/Α N/A
10/08/2027 11/08/2027 19/08/2027 23/08/2027 30/08/2027 01/09/2027 09/09/2027
07/09/2027 08/09/2027 16/09/2027 20/09/2027 27/09/2027 29/09/2027 07/10/2027
06/10/2027 07/10/2027 15/10/2027 19/10/2027 26/10/2027 28/10/2027 05/11/2027
02/11/2027 03/11/2027 11/11/2027 15/11/2027 22/11/2027 24/11/2027 02/12/2027
17/12/2027 20/12/2027 30/12/2027 03/01/2028 10/01/2028 12/01/2028 20/01/2028
2028
18/01/2028 19/01/2028 27/01/2028 31/01/2028 07/02/2028 09/02/2028 17/02/2028
15/02/2028 16/02/2028 24/02/2028 28/02/2028 06/03/2028 08/03/2028 16/03/2028
13/03/2028 14/03/2028 22/03/2028 27/03/2028 31/03/2028 04/04/2028 12/04/2028
12/04/2028 13/04/2028 21/04/2028 25/04/2028 02/05/2028 04/05/2028 12/05/2028
16/05/2028 17/05/2028 25/05/2028 29/05/2028 05/06/2028 07/06/2028 15/06/2028
13/06/2028 14/06/2028 22/06/2028 26/06/2028 03/07/2028 05/07/2028 13/07/2028
N/A N/A N/A N/A N/A N/A N/A
08/08/2028 09/08/2028 17/08/2028 21/08/2028 28/08/2028 30/08/2028 07/09/2028
05/09/2028 06/09/2028 14/09/2028 18/09/2028 25/09/2028 27/09/2028 05/10/2028
10/10/2028 11/10/2028 19/10/2028 23/10/2028 30/10/2028 01/11/2028 09/11/2028
07/11/2028 08/11/2028 16/11/2028 20/11/2028 27/11/2028 29/11/2028 07/12/2028
EMA/219234/2026 Page 44/46
第 45 页
Responses to the list of outstanding issues – 3rd phase (30-day assessment after clock-
stop for outstanding issues or after oral explanation) (accelerated assessment)
Submission date Clock restart (day Joint AR Draft CVMP AR CVMP comments on Adoption of opinion
181) joint AR
2026
13/01/2026 14/01/2026 23/01/2026 23/01/2026 30/01/2026 12/02/2026
10/02/2026 11/02/2026 20/02/2026 20/02/2026 27/02/2026 12/03/2026
17/03/2026 18/03/2026 27/03/2026 27/03/2026 03/04/2026 16/04/2026
21/04/2026 22/04/2026 01/05/2026 01/05/2026 08/05/2026 21/05/2026
19/05/2026 20/05/2026 29/05/2026 29/05/2026 05/06/2026 18/06/2026
16/06/2026 17/06/2026 26/06/2026 26/06/2026 03/07/2026 16/07/2026
N/A N/A N/A N/A N/A N/A
11/08/2026 12/08/2026 21/08/2026 21/08/2026 28/08/2026 10/09/2026
08/09/2026 09/09/2026 18/09/2026 18/09/2026 25/09/2026 08/10/2026
06/10/2026 07/10/2026 16/10/2026 16/10/2026 23/10/2026 05/11/2026
03/11/2026 04/11/2026 13/11/2026 13/11/2026 20/11/2026 03/12/2026
18/12/2026 21/12/2026 04/01/2027 04/01/2027 08/01/2027 21/01/2027
2027
19/01/2027 20/01/2027 29/01/2027 29/01/2027 05/02/2027 18/02/2027
16/02/2027 17/02/2027 26/02/2027 26/02/2027 05/03/2027 18/03/2027
16/03/2027 17/03/2027 26/03/2027 26/03/2027 02/04/2027 15/04/2027
20/04/2027 21/04/2027 30/04/2027 30/04/2027 07/05/2027 20/05/2027
18/05/2027 19/05/2027 28/05/2027 28/05/2027 04/06/2027 17/06/2027
15/06/2027 16/06/2027 25/06/2027 25/06/2027 02/07/2027 15/07/2027
10/08/2027 11/08/2027 20/08/2027 20/08/2027 27/08/2027 09/09/2027
EMA/219234/2026 Page 45/46
第 46 页
Submission date Clock restart (day Joint AR Draft CVMP AR CVMP comments on Adoption of opinion
181) joint AR
07/09/2027 08/09/2027 17/09/2027 17/09/2027 24/09/2027 07/10/2027
06/10/2027 07/10/2027 15/10/2027 15/10/2027 22/10/2027 05/11/2027
02/11/2027 03/11/2027 12/11/2027 12/11/2027 19/11/2027 02/12/2027
17/12/2027 20/12/2027 31/12/2027 31/12/2027 07/01/2028 20/01/2028
2028
18/01/2028 19/01/2028 28/01/2028 28/01/2028 04/02/2028 17/02/2028
15/02/2028 16/02/2028 25/02/2028 25/02/2028 03/03/2028 16/03/2028
13/03/2028 14/03/2028 23/03/2028 23/03/2028 30/03/2028 12/04/2028
12/04/2028 13/04/2028 21/04/2028 21/04/2028 28/04/2028 12/05/2028
16/05/2028 17/05/2028 26/05/2028 26/05/2028 02/06/2028 15/06/2028
13/06/2028 14/06/2028 23/06/2028 23/06/2028 30/06/2028 13/07/2028
08/08/2028 09/08/2028 18/08/2028 18/08/2028 25/08/2028 07/09/2028
05/09/2028 06/09/2028 15/09/2028 15/09/2028 22/09/2028 05/10/2028
10/10/2028 11/10/2028 20/10/2028 20/10/2028 27/10/2028 09/11/2028
07/11/2028 08/11/2028 17/11/2028 17/11/2028 24/11/2028 07/12/2028
EMA/219234/2026 Page 46/46
来源：EMA Regulatory and Procedural Guidelines · ema.europa.eu