The European Medicines Agency (EMA) has presented the three-year work plan for the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG) for the period from January 2026 to December 2028. The document, prepared under the leadership of the group’s chair, Brendan Cuddy, outlines the priorities of European regulators: regulating artificial intelligence, preventing falsified medicines from entering supply chains, and modernizing drug quality oversight.
The new plan is developed in accordance with the European Medicines Agencies Network Strategy (EMANS) to 2028. The main focus is on “Theme 5” of the strategy, which aims to reinforce oversight, protect supply chain integrity, and increase inspector capacity.
Digitalization, AI, and New Technologies in Manufacturing
The Working Group has planned an update of GMP rules taking into account technological progress, including the implementation of digital technologies and artificial intelligence. It is expected that by the fourth quarter of 2026, the final texts will be prepared for the European Commission on the following key documents:
- New Annex 22 (Artificial Intelligence): Regulates the use of artificial intelligence in the context of GMP.
- Updated Annex 11 (Computerised Systems) and Chapter 4 (Documentation): Will undergo changes to ensure data integrity.
In addition, the publication of new clarifications (Q&A) on technological areas such as 3D printing is planned.
Combating Falsification and the Approach to Inspections
EMA plans to strengthen supply chain oversight to prevent the entry of falsified medicines. A new guidance for wholesale distributors will be issued on performing risk assessments when verifying the authenticity of medicines at risk of falsification.
Changes will affect the inspection methodology: priority is given to risk-based planning, as well as hybrid inspections and distant assessment to verify GMP compliance. The modernization of the EudraGMDP database is planned, where all EU member states are required to enter data on human and veterinary products.
Updating GMP Standards
The plan for 2026–2028 includes a review of several basic requirements of good manufacturing practice. By the fourth quarter of 2026, it is planned to update:
- Chapter 1 (Pharmaceutical Quality System): To integrate elements of the ICH Q9(R1) guideline.
- Annex 15 (Qualification and Validation): Taking into account new technologies, updated risk management requirements, and extending the scope to active pharmaceutical ingredients (APIs).
- Specialized guidelines for Advanced Therapy Medicinal Products (ATMPs).
By the fourth quarter of 2028, the regulator intends to finalize updated versions of Chapter 3 (Premises and Equipment), Chapter 5 (Production), Chapter 7 (Outsourced Activities), and Chapter 9 (Self-Inspection). By the same deadline, annexes on the manufacture of radiopharmaceuticals (Annex 3), medicinal gases (Annex 6), and products derived from human blood or plasma (Annex 14) will be updated.
International Cooperation
The plan emphasizes the importance of international cooperation within the framework of mutual recognition agreements (MRA) with Australia, Canada, Israel, Japan, New Zealand, Switzerland, and the USA. Special attention is paid to maintaining the GMP aspects of the trade agreement between the EU and the UK.
EMA will continue joint initiatives on training in EU GMP standards with regulatory authorities in India and China, and will also provide expert support to the emerging African Medicines Agency through specialized training.
