Swissmedic 自 2026 年 11 月 15 日起要求原料药预先登记于 EMA SMS 数据库方可列入生产许可与 GMP 证书
Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
Swissmedic 宣布，自 2026 年 11 月 15 日起原料药须预先登记于 EMA 的 SMS 数据库，否则无法列入生产许可和 GMP 证书。该要求覆盖首次申请、变更申请及检查后签发，纸质和电子版本均适用。企业现须在表格 I-301.AA.05-A02-A03d 第 3.8 节提交英文原料药清单（名称与 SMS ID），尚未登记的可通过 EMA Service Desk 提交登记申请。
材料说明原料药需预先登记于 EMA SMS 数据库方可列入生产许可与 GMP 证书，并列出企业须提交的清单及联系方式。
Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
As of 15 November 2026, the prior registration of active substances in the EMA SMS database (Substances Management Services) will become a mandatory requirement for their inclusion in establishment licences and GMP certificates
01.10.2026
From now on, owing to modifications in the EudraGMDP database, active substances that have to be listed in section 3.8 of establishment licences and GMP certificates will have to be registered in advance in the Substance Management Services (SMS) active substances database of the European Medicines Agency (EMA) (SPOR Web UI (europa.eu)).
As of 15 November 2026, Swissmedic will no longer be able to issue establishment licences and GMP certificates with a list of active substances if the submitted active substances have not been registered in advance in the SMS active substances database. This applies to both hardcopy and electronic versions (SwissGMDP or EudraGMDP).
This principle applies regardless of whether documents are being issued for the first time (application for first establishment licence) or in response to applications for a change to an existing licence or following an inspection. It is therefore essential that all active substances listed in Swiss manufacturers’ establishment licences / GMP certificates are registered in the SMS database.
As of today, manufacturers of active substances must:
- Ensure that active substances listed in their establishment licence under section 3.8 of form I-301.AA.05-A02-A03d Gesuch Betriebsbewilligung - Zusatzblatt Arzneimittel (inkl. Blut) [Application for an establishment licence – medicinal products supplementary sheet (including blood)] are correctly registered in the SMS database
- When making a new application for an establishment licence or a change to a licence, submit to Swissmedic a list of their active substances as registered in the SMS database (name + SMS ID) in English under section 3.8 of form I-301.AA.05-A02-A03d Gesuch Betriebsbewilligung - Zusatzblatt Arzneimittel (inkl. Blut) [Application for an establishment licence – medicinal products supplementary sheet (including blood)]
- Communicate to Swissmedic a list of active substances as registered in the SMS database (name + SMS ID) by sending a hardcopy letter citing the application number to Swissmedic, Swiss Agency for Therapeutic Products, Operational Support Services Division, Hallerstrasse 7, 3012 Bern, Switzerland or an email to [email protected] if their organisation has a pending application for an establishment licence for the manufacture of active substances and the active substances in question have to be referenced in the establishment licence or the organisation has just been inspected.
Active substances already registered in the SMS active substances database can be downloaded as an Excel table (SMS Export lists).
If any active substance has not yet been registered in SMS, companies can submit a request for registration of an active substance via the EMA Service Desk using the Substance Request Form.
Swissmedic is not responsible for the management of active substances registered in the SMS database. Affected companies must ensure that the responsible staff members within their organisation have registered for an EMA account and submitted a request for a SPOR role.
The links below provide additional information on the SMS database and the associated services.
来源：Swissmedic 药品质量与 GMP 更新 · swissmedic.ch