The European Medicines Agency (EMA) has published a new version of the ‘3-year work plan for the Inspectors Working Group’ covering the period from January 2026 to December 2028.
This workplan sets out the routine activities of the GMDP IWG that contribute to the overall strategic objectives of the European Medicines Regulatory Network (EMRN). This GMDP IWG 3-year workplan is developed to complement the European Medicines Agencies Network Strategy (EMANS) 2028, “Seizing Opportunities In A Changing Medicines Landscape” strategic objectives and goals,
which has a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain.
This workplan includes specific activities to achieve the overall strategic objective of Theme 5 to “reinforce the oversight and protection of the supply chain and increase inspector capacity”.
In addition, the work of the GMDP IWG also may indirectly support the objectives of other thematic areas such as innovation and network capacity.
The work plan of the EMA Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG) is published for transparency and informational purposes. It reflects the planned activities and priority work items identified by the GMDP IWG at the time of publication.
The work plan shall be regularly reviewed and updated as necessary. Additional topics may be identified, and ongoing items may be adjusted, reprioritised, or expanded in response to regulatory developments, emerging public health needs, international collaboration activities or other considerations relevant to the mandate of the GMDP IWG.
Any new or revised work items will be reflected in this document or in the subsequent work plan.
Such changes may be communicated through the appropriate EMA channels, where necessary.