BASG and healthcare professionals
News
Accelerated procedure for mononational studies Top-News
messages in brief
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03/06/2025
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.
Accelerated procedure for mononational studies
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New process for combination studies Top-News
messages in brief
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02/06/2025
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.
New process for combination studies
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CHMP Meeting Highlights June 2025 New
messages in brief
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24/07/2025
Up-to-date information from the 16.06.-19.06.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
CHMP Meeting Highlights June 2025
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Coordination and management of medical device regulation at EU level
messages in brief
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14/07/2025
Publication of a joint declaration by the competent national EU authorities to the EU Commission.
Coordination and management of medical device regulation at EU level
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New Export Option for Packaging Master Data in eService Marketing Authorisation and Lifecycle Management
messages in brief
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02/07/2025
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).
New Export Option for Packaging Master Data in eService Marketing Authorisation and Lifecycle Management
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