Austria is sending a clear signal in favour of research-friendly framework conditions. For clinical trials in accordance with Regulation (EU) No. 536/20214 that are conducted exclusively in Austria, EU-wide coordination is no longer required. The new procedure significantly shortens the authorisation period.

The regulatory processes for combined medicinal product and medical device studies are being simplified in Austria. The new regulation for lead ethics committees harmonises the responsibilities of the ethics committees and enables a coordinated assessment. As a result, combination studies will start faster and more smoothly in future.

Publication of a joint declaration by the competent national EU authorities to the EU Commission.

Starting in July 2025, BASG/AGES MEA will provide an Excel export of the packages available in our database for each human medicinal product. This is also intended to support data entries in SPOR-PMS and XEVMPD (Article 57). Detailed information can be found in the following guide (L_Z34).

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.