Please note that requests for JSCs should only be submitted during the request periods published in the Annual Work Programme of the HTACG. In 2025, these periods are:•3 February to 3 March 2025 for medicinal products only;•2 to 30 June 2025 for medicinal products and medical devices.Available consultation slots to apply for in the first
There is a new guideline on Quality Non Clinical and Clinical requirements for investigational ATMP, which is coming into effect on 1 Jul 2025 if you want to be updated regarding this new guideline, contact RegPharmaClin S.L. for a Course on this New Guideline related to IMPD for a CTA. A Certificate of Attendance will
From 31 January 2025 onwards only the Clinical Trials Regulation (EU) 536/2014 (CTR) and its Delegated Acts will apply, as laid down in Article 98 thereof. Ongoing clinical trials currently governed by the Clinical Trials Directive (CTD) and expected to continue after 30 January 2025 will need to transition to the CTR regulatory framework. If such clinical
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