CMDh – the road ahead to 2028

The Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) has recently published its Multi-annual Workplan to 2028 , outlining its priorities across four main areas:

1. Optimisation of procedures – described more in detail below
2. Information technology and digitalisation – leveraging digital tools to improve efficiency and promote the use of AI where appropriate
3. Training – strengthening the EU regulatory network
4. Implementation of the new pharmaceutical legislation relevant to CMDh procedures

A significant part of the workplan focuses on optimising regulatory procedures. Several initiatives have been identified to simplify and facilitate the application process for applicants.

For slot-booking several initiatives are underway:

• Increased transparency, including publication of booking information from national agency websites via the CMDh website
• Faster responses to slot requests
• Sharing of best practices to improve submission predictability and enhance understanding of cancellations and postponements
• Consideration of a pilot for a centralised booking list

CMDh is also exploring improvements to validation procedures, with a focus on enhancing communication between national authorities and harmonising validation practices. The aim is to improve submission quality through clearer guidance, robust validation checklists, and more consistent instructions.

Related to this, parallel assessment procedures are being reviewed to strengthen cooperation among Member States across different stages and to identify and promote best practices.

For the Mutual recognition procedure (MRP) and Repeat-use procedure (RUP) further harmonisation efforts are under consideration to align assessment processes between the RMS and the CMS. Obstacles in the national phase implementation are being identified and analysed, and appropriate actions will be proposed based on the findings.

Finally, several initiatives are planned for variations, many of which are linked to digitalisation efforts, such as the development of web-based application forms.

Overall, these initiatives reflect a clear emphasis on streamlining regulatory processes and improving efficiency across CMDh procedures, with the end goal of easing the regulatory burden for marketing authorisation applicants and holders.