EMA药物警戒检查员工作组2025年度报告（EMA/INS/PhV/59453/2026）
Annual report of the Pharmacovigilance Inspectors Working Group for 2025
EMA药物警戒检查员工作组（PhV IWG）于2026年10月1日通过其2025年度报告，文件编号EMA/INS/PhV/59453/2026，系该工作组第十六份年度报告。报告涵盖2025年3月6-7日、6月5-6日、9月25-26日及11月13日举行的四次全体会议，并涉及集中授权产品药物警戒检查发现分类及人用与兽用药物警戒立法协调等议题。
PDF 文字版；图形和原始排版请参阅官方 PDF。
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01 October 2026
EMA/INS/PhV/59453/2026
Quality and Safety of Medicine Department
Inspections Office
Annual report of the Pharmacovigilance Inspectors
Working Group for 2025
Adopted by the PhV IWG on 01 October 2026
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union
© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.
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List of Abbreviations
ADR Adverse drug reactions
AE Adverse Event
CAP Centrally Authorised Product
CAPA Corrective And Preventive Actions
CHMP Committee for Medicinal Products for Human Use
CVMP Committee for Veterinary Medicinal Products
DWH Data Warehouse
EEA European Economic Area
EU European Union
EVCTM EudraVigilance Clinical Trial Module
EVDAS EudraVigilance Data Analysis System
EVPM EudraVigilance Post-Authorisation Module
EV-Vet EudraVigilance-Veterinary
GCP Good Clinical Practices
GVP Good Pharmacovigilance Practices
ICSR Individual Case Safety Report
KPI Key Performance Indicators
MAH Marketing Authorisation Holder
MS Member State
NCA National Competent Authority
PhV IWG Pharmacovigilance Inspectors Working Group
PhVWP-V Pharmacovigilance Working Party (Veterinary Medicinal Products)
PIC Pharmaceutical Inspection Co-operation Scheme
PRAC Pharmacovigilance Risk Assessment Committee (Human Medicinal Products)
PSMF Pharmacovigilance System Master File
QMS Quality Management System
QPPV Qualified Person responsible for Pharmacovigilance
VGVP Guideline on Veterinary Good Pharmacovigilance Practices
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Table of contents
1. Introduction ............................................................................................ 4
2. Meetings .................................................................................................. 5
3. Pharmacovigilance inspections relating to centrally authorised medicinal
products ...................................................................................................... 6
3.1. General overview ................................................................................................. 6
3.2. Categorisation of findings for CHMP requested inspections conducted in 2025 .............. 8
3.3. Categorisation of findings for CVMP requested inspections conducted in 2025 .............. 9
4. Harmonisation topics............................................................................. 10
4.1. Human pharmacovigilance legislation .................................................................... 10
4.2. Implementation of the new veterinary pharmacovigilance legislation ........................ 10
4.3. Joint inspections................................................................................................. 10
4.4. Training and development ................................................................................... 10
4.5. Medicinal products for human use ........................................................................ 11
4.6. Medicinal products for veterinary use .................................................................... 12
5. Liaison with other groups ...................................................................... 13
5.1. Interaction with the PRAC .................................................................................... 13
5.2. Interaction with the CVMP Pharmacovigilance Working Party ................................... 13
5.3. Communication with the public and external bodies ................................................ 13
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1. Introduction
This document is the sixteenth annual report of the Pharmacovigilance Inspectors Working Group (PhV
IWG). The PhV IWG was established by the European Medicines Agency (hereinafter “the Agency”)
within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004. Following a report on its first year
of operation, the PhV IWG mandate was endorsed by the Heads of Medicines Agencies on 18-19 May
2009 and by the Agency’s Management Board on 1 October 2009, thereby formally establishing the
PhV IWG.
The PhV IWG focuses on the harmonisation and coordination of pharmacovigilance-related activities at
EU (hereinafter the "Union") level. The group's role and activities are described in more detail in its
work plan. The group supports the coordination of the provision of pharmacovigilance inspection-
related advice and provides a link to other groups such as the Committee for Medicinal Products for
Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP), the Pharmacovigilance
Risk Assessment Committee (Human Medicinal Products) (PRAC), and the Pharmacovigilance Working
Party (Veterinary Medicinal Products) (PhVWP-V).
This annual report for 2025 has been drawn up in line with the format and objectives of the 2024-2026
work plan.
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2. Meetings
The plenary meetings, involving pharmacovigilance inspectors working with human medicinal products
and pharmacovigilance inspectors working with veterinary medicinal products, were held on the
following dates:
• 06-07 March 2025 (virtual meeting);
• 05-06 June 2025 (hybrid meeting);
• 25-26 September 2025 (hybrid meeting);
• 13 November 2025 (virtual meeting).
Meetings included a joint session of relevance to both human and veterinary matters, and two separate
sessions which dealt with human and veterinary matters separately.
A hybrid meeting between industry stakeholder representatives for veterinary medicinal products, the
Pharmacovigilance Working Party (PhVWP-V) and the PhV IWG was held at EMA on 21 May 2025.
On 26 September 2025 part of the PhV IWG plenary meeting was dedicated to a meeting with industry
stakeholder representatives for human medicinal products. In addition, several virtual meetings took
place using teleconferencing or equivalent settings:
• For human medicinal products: ad hoc presentations on pharmacovigilance inspection topics have
been delivered to the PRAC meetings, as necessary.
• For veterinary medicinal products: ad hoc presentations on pharmacovigilance inspection topics
were organised for the PhVWP-V meetings, as necessary.
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3. Pharmacovigilance inspections relating to centrally
authorised medicinal products
3.1. General overview
For human medicinal products, the CHMP with input from the PRAC and in conjunction with the
competent authority of the Member State in whose territory the pharmacovigilance system master file
is located (hereafter known as the supervisory authority) and the inspectors’ working group, have
created and maintained a programme for inspection in relation to CAPs, in accordance with GVP
Module III on pharmacovigilance inspections and the Union procedure on the coordination of EU
pharmacovigilance inspections.
For veterinary medicinal products, the CVMP supported by the Pharmacovigilance Working Party, in
conjunction with the supervisory authority and the inspectors’ working group, have created and
maintained a programme for inspection in relation to CAPs, in accordance with VGVP Module on
Controls and pharmacovigilance Inspections and the Union procedure on the coordination of veterinary
pharmacovigilance inspections.
The inspections covered by these programmes are prioritised based on the potential risk to public
health, the nature of the products, the extent of use, the number of products that the MAH has on the
EEA market and other risk factors listed in GVP Module III on pharmacovigilance inspections and VGVP
Module on Controls and pharmacovigilance Inspections.
The focus of these inspections is to determine whether the MAH has the personnel, systems, and
facilities in place to meet its regulatory pharmacovigilance obligations for CAPs in the EEA. These
inspections are requested as system inspections with one or more specific products selected as
examples, for which specific information can be traced and verified through the various processes. This
provides practical evidence for the functioning of the MAH’s pharmacovigilance system in the Union
and its compliance with the regulatory requirements.
In general, it is anticipated that national inspection programmes will fulfil the need for the routine
inspections included in this programme and therefore it is expected that the inspection programme is
achieved mainly through the national programmes. However, there are situations where these
inspections might be specifically requested by the CHMP or CVMP, as applicable (e.g. global
pharmacovigilance sites in third countries; additional sites within the Union are identified for inspection
and require joint inspections involving the Member State concerned by that site and the supervisory
authority). For-cause inspections are also reflected in this programme as they may replace the need
for routine inspections.
Since September 2022, the coordination of pharmacovigilance inspections requested by EMA’s
committees for human and veterinary medicines under the centralised procedure has been managed
through the IRIS platform, a secure online platform for handling product-related scientific and
regulatory procedures, that EMA launched in 2018, as part of EMA's digital transformation programme.
The project to redesign the procedure for preparing and maintaining the risk-based programme for
routine pharmacovigilance inspections of MAHs of CAPs for both human and veterinary medicines,
launched in 2024, was finalised in 2025.
The results presented in Tables 1 and 2 show, respectively, the number of inspections conducted in
relation to the human and veterinary pharmacovigilance inspection programmes in 2025, broken down
by the type of site inspected.
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Table 1 - Human pharmacovigilance inspections conducted in 2025 in the context of the programme
for the pharmacovigilance inspection of companies with CAPs
2025 QPPV/PSMF Global PhV Subcontractor/ Total
(MAH) site site Licensing partner/affiliate site
CHMP requested 2 0 5 7
National inspection
42 0 10 52
programmes
Total 44 0 15 59
Table 2 - Veterinary pharmacovigilance inspections conducted in 2025 in the context of the
programme for the pharmacovigilance inspection of companies with CAPs
2025 QPPV/PSMF Global Subcontractor/ Total
(MAH) site PhV site Licensing partner/affiliate site
CVMP requested 2 0 1 3
National inspection
3 0 0 3
programmes
Total 5 0 1 6
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3.2. Categorisation of findings for CHMP requested inspections conducted
in 2025
A total of 88 deficiencies, comprising 0 critical, 35 major (39.8%) and 53 minor (60.2%) findings were
recorded for the CHMP requested human medicines pharmacovigilance inspections conducted in 2025
(period covered from 01/01/2025 until 31/12/2025).
The main findings observed during inspections conducted in 2025 are detailed in Figure 1 in
accordance with the categorisation of pharmacovigilance inspection findings agreed by the PhV IWG.
The three most common areas with findings identified during inspections conducted in 2025 were the
following:
• Management and reporting of adverse reactions;
• Quality Management System (QMS);
• Computerised systems.
Figure 1 - Number of findings related to the main categories graded as critical, major, and minor for
CHMP requested inspections conducted in 2025
A total of 22 findings were identified in the area of management and reporting of adverse reactions. Of
these, seven were classified as major findings, related to quality control process, submissions and
follow-up processes, assessment of seriousness, causality and expectedness, medical review and
MedDRA coding, as well as the receipt of Individual Case Safety Reports (ICSRs) from all sources and
their collation at a single point within the EU.
The remaining fifteen findings were classified as minor and were associated mainly with the submission
and follow-up processes, and the rest with literature screening, quality control process, medical review
and MedDRA coding, as well as the receipt of ICSRs from all sources and collection and collation at a
single point within the EU.
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3.3. Categorisation of findings for CVMP requested inspections conducted
in 2025
A total of 23 deficiencies, comprising 0 critical, 10 major (43.48%) and 13 minor (56.52%) findings
were recorded for the CVMP requested veterinary medicines pharmacovigilance inspections conducted
in 2025 (period covered from 01/01/2025 until 31/12/2025).
The main findings observed during inspections conducted in 2025 are detailed in Figure 2 in
accordance with the categorisation of pharmacovigilance inspection findings agreed by the PhV IWG.
The most common area with findings identified during inspections conducted in 2025 was Quality
Management System (QMS).
Figure 2 - Number of findings related to the main categories graded as critical, major, and minor for
CVMP requested inspections conducted in 2025
QMS deficiencies represented the most frequently cited inspection findings, accounting for a total of
nine findings. Of these, five were classified as major findings, including three related to audit and CAPA
processes and two related to document management systems. The remaining four were classified as
minor findings, comprising two related to training, one related to KPIs, and one related to document
management systems.
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4. Harmonisation topics
4.1. Human pharmacovigilance legislation
To support further harmonisation for the mutual recognition of pharmacovigilance inspections within
the Union and in connection with human medicinal products, in 2025 the group was involved in the
revision of the:
• GVP Module XVI Addendum I – Risk minimisation measures for medicinal products with
embryo-fetal risks
• GVP Module VI Addendum II – Masking of personal data in individual case safety reports
submitted to EudraVigilance
• GVP Product- or population-specific considerations III: Pregnant and breastfeeding women and
their children exposed in utero or via breastmilk
4.2. Implementation of the new veterinary pharmacovigilance legislation
To support the implementation of the new pharmacovigilance legislation and in connection with
veterinary medicinal products in 2025 the group continued supporting the development of
pharmacovigilance compliance monitoring reports for inspectors.
The group was also involved in the revision of existing guidance and Q&A:
- Guideline on veterinary good pharmacovigilance practices (VGVP) Module on Pharmacovigilance
systems, their Quality Management Systems and pharmacovigilance system master files (ongoing)
- Veterinary pharmacovigilance inspections: Q&As
4.3. Joint inspections
From the total of 7 CHMP pharmacovigilance site inspections conducted in 2025, 5 inspections were
joint inspections involving more than one MS (see Table 1 in Section 3).
The 3 CVMP pharmacovigilance site inspections conducted in 2025 were joint inspections involving
more than one MS (see Table 2 in Section 3).
4.4. Training and development
A hybrid Pharmacovigilance Inspectors' Working Group training course took place, 27-28 November
2025. The training organisation was supported by the programme committee Germany (BVL),
Denmark (Danish Medicines Agency) and Austria (AGES). Participants included inspectors and
assessors from both veterinary and human units of Member States (Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Iceland, Italy,
Latvia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden)
as well as inspectors, assessors/experts from non-EU countries (Albania, Australia, Azerbaijan,
Barbados, Brazil, Bosnia and Herzegovina, Canada, Moldova, Montenegro, Mozambique, Peru,
Republic of North Macedonia, Serbia, Thailand, Türkiye, Ukraine, UK).
• Key objectives of the training:
− to promote awareness and better understanding of legislation and/or guidance, as applicable,
with focus on good pharmacovigilance practices (GVP) and Union procedures on
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pharmacovigilance inspections and their implementation in relation to human medicinal
products;
− to promote awareness and better understanding of the New Veterinary Medicinal Products
Regulation (Regulation (EU) 2019/6 and Commission Implementing Regulation (EU)
2021/1281) and guidance, as applicable, and its implementation in relation to veterinary
medicinal products;
− to share experiences from inspections (human and veterinary) conducted by individual MS to
promote further harmonisation of inspection approaches and sharing best practices;
− to build understanding, promote further interaction between assessors and inspectors and
improve the coordination of inspection and the verification of pharmacovigilance compliance.
• The following topics were presented and/or discussed in the human and veterinary medicinal
products related workshops:
- Signal management;
- Special features of big and small companies and their inspection.
• The following topics were presented and/or discussed in the human medicinal products related
workshops:
- Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation
measures – implementation of Rev 3;
- Guideline on good pharmacovigilance practices (GVP) Module II - Pharmacovigilance System
Master File (PSMF) findings and harmonisation of expectations;
- Extended EudraVigilance medicinal product dictionary (XEVMPD);
- Harmonisation in grading of findings.
• The following topics were presented and/or discussed in the veterinary medicinal products related
workshops:
− Signal management process & EudraVigilance Veterinary Data Warehouse (EV-Vet DWH);
− PSMF expectations and harmonisation of findings;
− Harmonisation in grading of findings.
4.5. Medicinal products for human use
• The PhV IWG has prepared and is maintaining the risk-based programme for routine
pharmacovigilance inspections of MAHs related to human CAPs.
• Pharmacovigilance inspectors also provided recommendations to the PRAC in relation to
pharmacovigilance inspections or related assessment issues.
• During the PhV IWG meetings held in 2025, discussions on the following topics took place:
− Revision of the PhV IWG work plan for 2024-2026;
− Sharing and discussion of inspection report findings;
− Sharing of pharmacovigilance inspection information;
− Development of peer review of case studies;
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− EudraVigilance and EudraVigilance Data Analysis System (EVDAS);
− Digital Business Transformation - EMA inspection coordination;
− Risk-based inspection planning;
− Use of automation and AI applications in pharmacovigilance;
− Queries on guidance/legislation interpretation;
− PIC/S activities in the field of PhV inspections (GVP Best Practices and Artificial Intelligence-
Machine Learning Working Groups).
• During the stakeholder meeting in 2025, discussions on the following topics took place:
- Inspection and information sharing;
- PSMF Expectations and harmonisation;
- Harmonisation of data points to be included in routine ICSR line listings generated for
inspections;
- Inspection of AI.
4.6. Medicinal products for veterinary use
• The PhV IWG has prepared and is maintaining the risk-based programme for routine
pharmacovigilance inspections of MAHs related to veterinary CAPs. These programmes (human and
veterinary) are not publicly available as they contain confidential information.
• During the PhV IWG meetings held in 2025, discussions on the following topics took place:
− Revision of the PhV IWG work plan for 2024-2026;
− Regulation (EU) 2019/6 on veterinary medicinal products, corresponding implementing and
delegated acts and guidance, as applicable;
− Development of peer review of case studies;
− Sharing and discussion of inspection report findings;
− EV-Vet DWH;
− Digital Business Transformation - EMA inspection coordination;
− Risk-based inspection planning;
− Use of automation and AI applications in pharmacovigilance;
− Queries on guidance/legislation interpretation;
− PIC/S activities in the field of PhV inspections (GVP Best Practices and Artificial Intelligence-
Machine Learning Working Groups).
• During the Pharmacovigilance Working Party (PhVWP-V)-PhV IWG Interested Parties meeting held
in 2025, inspectors shared the experiences gained from pharmacovigilance inspections performed
under the new veterinary Regulation (EU) 2019/6.
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5. Liaison with other groups
5.1. Interaction with the PRAC
• The PhV IWG interacted with assessors on topics related to:
− Issues identified during inspections and follow-up, as necessary;
− Preparation and maintenance of the risk-based programme for routine pharmacovigilance
inspections of MAHs connected with human CAPs.
5.2. Interaction with the CVMP Pharmacovigilance Working Party
• The PhV IWG interacted with assessors on topics related to:
− Regulation (EU) 2019/6 on veterinary medicinal products, corresponding implementing and
delegated acts and guidance, as applicable;
− Updates on inspections planned and conducted;
− Follow-up of pharmacovigilance inspections;
− Preparation and maintenance of the risk-based programme for routine pharmacovigilance
inspections of MAHs connected with veterinary CAPs.
5.3. Communication with the public and external bodies
• Delegates from the PhV IWG have participated and/or given presentations on behalf of the group in
different European conferences and meetings covering different topics of public interest:
- DIA Global Forum for QPPV, Amsterdam 19-20 November 2025;
- EudraVigilance Expert Working Group (EV-EWG) on an ad hoc basis as additional domain
experts on pharmacovigilance areas of common interest to the PhV IWG and EV-EWG;
- PIC/S meetings: GVP Best Practices and Artificial Intelligence-Machine Learning Working
Groups.
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来源：EMA Inspections · ema.europa.eu