GDPA Participated as an Observer in the EMA GMDP-IWG Interested Parties Meeting

On 11 June 2026, the "Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group Interested Parties Meeting" took place online. Alfred Hunt, Chairman of the European GDP Association (GDPA) attended on behalf of GDPA as an observer, supporting the association in staying closely connected to regulatory discussions and tracking upcoming GDP developments early.

The agenda shared with Interested Parties covered, among other topics, the GMDP IWG Workplan 2026-2028, inspection reliance and inspection coordination, and, most relevant for the GDP community, a dedicated session on the "GDP Drafting Group". 

The timelines for the new pharmaceutical legislation within the EU was discussed, with the expectation being that the legislation will be formally adopted in Q4 2026 with application from Q4 2028. In the intervening period, delegated and implementing acts will be developed along with national legislation to implement the requirements.

During the meeting, Emil Schwan, the EMA coordinator of the GDP Drafting Group, outlined the key responsibilities and actions of the Group, which will consist of GDP inspectors from every member state. Included will be work topics for harmonisation and improvements in GDP topics and sharing of best practices for GDP interpretation and inspections. The Drafting Group will also prepare for and establish the Joint Audit Programme (JAP) for GDP inspectorates which is included within the revised pharmaceutical legislation.

An update on the EudraGMDP modernization project was provided. Users should observe the system updates for GMP/MIA in Q4 2026 and WDA / GDP / ASR in Q1 2027. Whilst no new functionalities are foreseen, performance will be improved, and user-focused capabilities will be delivered like global search, and transitioning to a modern platform.