EC: Q&As on Gradual Roll Out of EUDAMED

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework.

EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.

The ICH’s Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.