EMA: Annual Report 2022 Published and Workplan for GMDP Updated
As part of the recent publication of EMA's Annual Report 2022, the 3-year work plan 2021-2023 has also been updated. The 13-page work plan has been developed with a main focus on the network strategy and the scientific regulatory strategy (RSS). The security and resilience of the supply chain is of particular importance.
The value of the strategic goals are listed by their priority. Among other key objectives, the following are of primary importance:
- Enhance traceability, oversight and security in the human/veterinary medicine supply chain Die Umgesetzt erfolgt beispielsweise durch
- the expansion of the EudraGMDP database to facilitate the exchange of information on manufacturers, distributors, products and compliance; as well as
- the use of the new Veterinary Regulation, which relates to the distribution of veterinary medicines and active substances.
- Enhance inspector capacity building at EU and international level
- Analyse the possible implications of new manufacturing technologies in order to regulate the new supply chains needed
Various activities and projects have been developed to ensure the successful implementation.
Among others, a Joint Audit Programme will be established through collaboration with PIC/S and the MRA members. The Compliance Group (a subgroup of the GMDP IWG) will establish risk-based audit procedures and, using agency audit resources, develop a formal process for following up on key issues raised in the program.
In addition, the previously discussed EudraGMDP database was integrated into the EMA OMS on January 28th, 2022, to support regulatory activities across the European Union. The necessary changes to incorporate the database were identified and implemented in the Agency's Master Data Management project. This is to promote the EudraGMDP at the European and international level (RSS Goal 2).
Considering the final version of Annex 1 and continuous technical progress, the following guidance is scheduled to be reviewed and adjusted as necessary in the fourth quarter of 2024:
- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products (ATMPs)
- GMP Guide: Annex 15 Qualification and Validation (Exception: Q2 2024)
- GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release
- GMP Guide: Annex 4 (Manufacture Of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products)
- GMP Guide: Annex 5 (Manufacture Of Immunological Veterinary Medicinal Products)
In the first quarter of 2026, Chapter 4 Documentation and Annex 11 on Computerized Systems of the EU GMP Guide will also be revised.
Mutual Recognition Agreements
The MRAs with Australia, Canada, Israel, Japan, New Zealand, Switzerland, the USA and the UK remain unchanged.
In addition to MRAs, the following collaborations are worth mentioning
- the European Directorate for the Quality of Medicines and Healthcare (EDQM) in order to optimize the use of audit resources
- Collaborations with China and India to support joint activities and projects
- International cooperation on heparin supply chain monitoring (with international partners)
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