GMDP IWG Three-Year Work Plan: What's Planned for GDP?

On 23 March 2026, the European Medicines Agency (EMA) published two new documents from the GMDP Inspectors Working Group (GMDP IWG):

• the 3-year work plan for the Inspectors Working Group (January 2026 – December 2028), and
• the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2025

The documents and further background information are available on the EMA website.

The GMP/GDP IWG is a key EU forum for harmonising and coordinating GMP and GDP activities. As the annual report notes, the group “focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level and maintains close co-operation with the European Commission and with international partner authorities”.

3-Year Work Plan 2026–2028

The work plan aligns with the network strategy EMANS 2028, explicitly highlighting “supply chain integrity and resilience” and the need to “reinforce the oversight and protection of the supply chain and increase inspector capacity”.

A specific GDP-related item is the planned development of a Q&A to guide wholesalers in risk assessments for authenticity checks. The work plan states:

• "Develop a Q&A to provide guidance to WDA Holders on performing risk assessments on the verification of authenticity of medicinal products at risk of falsifications."

This sits within the broader objective to “strengthen monitoring and oversight of the supply chain to prevent entry of falsified human medicines in the supply chain”.

The work plan also points to several related topics that may affect GDP expectations and inspection practice, including:

• New or revised Union procedures with GDP aspects (CoUP)
• A planned procedure “on dealing with serious non-compliance with Good Distribution Practice”
• A review of the “Good Distribution Practice inspection procedure” to “formalise the risk based approach used for GDP inspection planning”
• "To continue to oversee the operation and maintenance of the EudraGMDP database and initiate the modernisation of the application to align with future regulatory and technological needs" and "to promote further use of the EudraGMDP as a tool for EU and international collaboration and reliance."
• "to develop contacts, collaboration and tailored training/workshops in the field of GMP and GDP inspections with EU candidate and accession countries identified by the European Commission."
• Monitoring legislative developments and assessing potential impacts on GDP and inspections

Annual Report 2025

The annual report describes the activities and developments of the GMP/GDP Inspectors Working Group in 2025.

The annual report confirms that 2025 marked the return to normal inspection operations, stating that “2025 marked the full return to normal operations for GMP and GDP inspections within the EEA and for third countries".

For GDP specifically, it notes that the GDP working group continued its work programme and held a joint meeting linked to GDP audit harmonisation: "An in-person meeting was held on 20-21 March 2025 as a joint meeting with the EU4H11 subgroup working on harmonisation and implementation of JAP for GDP".

In addition, the report mentions minor updates to EudraGMDP modules to reflect network needs.