The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released an updated Revision 8 of its Q&A document on generic applications, reflecting ongoing alignment with the evolving EU regulatory framework.
What’s new?
The January 2026 update introduces targeted but meaningful changes:
• Clarification of Question 8.b concerning the unavailability of the relevant strength of the reference product, now broadening the scope by removing the restriction to “oral” administration
• Additional guidance on enteral administration requirements for generics
• Minor editorial and formal updates for consistency
These changes follow the implementation of the revised Variations Regulation (EU) 2024/1701 and the updated EU Variations Guidelines effective January 2026, reinforcing the need for regulatory agility.
Why this matters?
The CMDh Q&A documents remain a critical reference point for industry, providing practical interpretation of requirements within MRP/DCP procedures and supporting consistent regulatory decision-making across EU member states.
For regulatory professionals, even seemingly small wording changes can have significant implications for dossier strategy, particularly when defining the scope of generic applications versus the reference product.
Key takeaway
Staying up to date with CMDh Q&A revisions is essential to:
– Avoid unnecessary deficiencies during assessment
– Ensure alignment with evolving EU expectations
-Optimize submission strategies for generics
Do you need support with your (generic) submissions, 0r broader Regulatory or Compliance activities? Contact us at [email protected] or visit our website at Starodub.nl.
