EMA's 3-Year Work Plan for GMDP Inspectors Working Group: What's Planned for GDP?

The European Medicines Agency (EMA) has published a three-year work plan (2025–2027) for the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group, along with the group’s annual report for 2024.

The documents and further information are available on the EMA homepage.

Three year work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2025-2027

It is pointed out that the "workplan is developed with a focus on the Network Strategy and Regulatory Science Strategy (RSS) goals, with a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain."

The plan defines strategic, tactical, and operational priorities across both GMP and GDP areas. Specifically for GDP, the following key points are highlighted:

• Implement the new Veterinary Regulation in the context of GDP for veterinary medicines and active substances.
• Create a dedicated GDP inspector training curriculum in collaboration with international partners and initiatives like PIC/S and EU4Health Joint Action.
• Develop a Q&A guide for Wholesale Distribution Authorization (WDA) holders to assist with risk assessments on verifying authenticity and managing the risk of falsified medicinal products (target date: Q4/2026).
• Gather GMP and GDP inspection related topics for development or revision of Union procedures.
• Formalize risk-based GDP inspection procedures.
• Create new procedures for managing serious GDP non-compliance.

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2024

The 2024 annual report of the GMDP Inspectors Working Group provides key insights into regulatory developments, inspection activities, and harmonisation efforts across the European Union.

Key GDP-related developments in 2024 include:

• On-site inspections had resumed in 2023, and EU inspectorates worked throughout 2024 to clear the backlog, especially for third-country sites.
• A specific working group for GDP was established and held its first meeting on 1 October 2024.
• Automatic extensions of GMP and GDP certificates ended in 2024.
• A Q&A on suspicious offers for wholesalers and brokers was published.
• A harmonized template for wholesale distribution authorisations was added to the Compilation of Union Procedures, supporting regulatory consistency.