Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

Europe At the end of January, EU Regulation 536/014 “Clinical trials” went into force. The entry into force of this Regulation resulted in the parallel updating of some international guidelines. In particular, a new version of the GMP Guide PE016 was...
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

News on the various Mutual Recognition Agreements (MRAs)

Europe On 19 April, the “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021” was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was...
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16

New Annex 21 for EU GMP published

Europe The new Annex 21 (C(2022) 843 final) was published by the European Commission on 16 February 2022 and will enter into force six months after its publication on 21 August 2022. The document provides a guideline on the import of medicinal products from...