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 published by PIC/S (Pharmaceutical Inspection Co-operation Scheme) on 1st February 2022. The revision included Annex 13 on the manufacturing of Investigational Medicinal Products (IMPs), and the new Annex 16 on the certification and batch release to be performed by Authorised Persons (AP) (click here to access all PIC/S guidance related to GMP). The goal of the revision of the PIC/S guidelines is to reflect the last changes that occurred in the corresponding EMA documents and thereby maintaining the alignment between PIC/S and EMA (as established by the cooperation agreement between both regulatory references). PIC/S has invited all non- EEA Participating Authorities and applicants to transpose the new Annexes 13 and 16 into their own GMP Guides.


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