Current issue of “RMS NEWS” New
A strong signal of trust and expertise: Austria acts as Reference Authority in a worksharing procedure for the 500th time! In early January 2026, the moment had arrived. For the 500th time, Austria was able to accept a worksharing request as Reference Authority. This milestone underscores Austria’s important role in European cooperation and the trust placed in its regulatory and expert assessment expertise. Furthermore, the Austrian authority’s strong 6th place in the CMDh statistics for 2025 is also worth noting, both in terms of variation worksharing procedures initiated and those completed.
Marketing authorisation holders can find all essential information on variation worksharing in Chapter 7 of the current CMDh Best Practice Guide.
In the CMDh’s Q&A document on variations, question 4.7 clarifies how the Reference Authority for a worksharing procedure should ideally be selected – this requires, in any case, the consent of the requested authority.
- RECENT COMMITTEE NEWS
CMDh Multi-Annual Work Plan. The CMDh has published a summary of its Multi-Annual Work Plan up to 2025. This outlines the measures that the CMDh, or the CMDh in collaboration with other stakeholders, has implemented in recent years in the following priority areas:
- Availability of critical medicines and coordination in times of crisis
- Optimisation of procedures
- Innovative projects
- Preparation for legislative changes
- Optimisation of communication with interested parties and stakeholders.
The CMDh is currently working on its Multi-Annual Workplan up to 2028 – this is also due to be published shortly.
MRP/DCP statistics for 2025. The CMDh has presented its annual statistics on DC/MR procedures for 2025, based on the CTS database. In 2025, Austria ranked 10th among Reference Member States (RMS) for finalised marketing authorisation procedures for human medicinal products, and 9th for procedures started! Thank you very much for your trust – we are delighted to continue to be your expert and reliable partner in authorisation procedures at European level!
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
