2025 CMDh Activities – What matters for industry stakeholders?

In November 2025 the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) celebrated its 20th anniversary, reflecting on achievements so far, and future challenges. CMDh has summarized this event and their other activities in 2025. Here are some highlights:

EU pharmaceutical legislation

A major milestone in 2025 was the provisional political agreement on the revision of EU pharmaceutical legislation. CMDh members contributed actively to these discussions and began preparing for implementation, which is expected to be a key priority in the coming years.

Strategic planning

In 2025 the CMDh worked on developing a new Multi‑Annual Workplan (MAWP) to 2028, building on the MAWP to 2025. Key priority areas include optimisation of procedures, IT and digitalisation, training, and the implementation of the new pharmaceutical legislation. Groups have been set up to define short-, medium- and long-term actions within these areas.

Procedures, assessments and variations

During the year CMDh continued working on improving MRP and DCP processes. This included e.g. updated guidance documents on submissions, updated RMS validation checklist, and updated templates for cover letters and RMS requests. To support procedure optimisation and gain knowledge on the current situation of slot booking and predictability of submissions, a survey was conducted among MSs.

Other CMDh guidance documents and templates, like assessment report templates were updated to improve the assessment process.

The CMDh guidance documents for the amended Variations Regulation and for the implementation of the new Variations Guideline, were updated e.g. with information on exceptional submissions of type IA variations outside of annual updates.

Pharmacovigilance and safety

In pharmacovigilance, the CMDh handled a substantial workload on referrals, PSUSA, PASS and PSUR follow‑up procedures, and updated guidance documents as needed. A temporary working group was created to improve the implementation of patient cards, and CMDh assumed responsibility for adopting final Good Pharmacovigilance Practice (GVP) modules following the discontinuation of the EU‑POG.

Safety topics that CMDh worked with during the year include nitrosamine impurities, genotoxicity concerns, and supply shortages.

Paediatrics, devices and digitalisation

In pediatrics the Best Practice Guide on Art. 45 and 46 was updated with regards to PI amendments.

The group updated guidance on medical devices and in vitro diagnostic regulations and strengthened cooperation with the Medical Device Coordination Group (MDCG) on combination products.

In digitalisation, progress continued with wider use of the PLM Portal web‑based electronic application form, and the CMDh guidance documents on national requirements for submissions were updated.

For a full list of new and updated CMDh documents, (guidances, templates, and Questions and Answers) from 2025 see the Annex of the CMDh summary.