PIC/S revises GMP guide to reflect new EU clinical trials regulation

Regulatory NewsRegulatory News | 01 February 2022 |  By 

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP) guide (PE 009-16) to reflect the new EU clinical trials regulation (CTR), which took effect on Monday after years of delays.
Specifically, Annex 13 of the PIC/S GMP guide, which relates to the manufacture of investigational medical products, is being replaced by the new EU Annex 13, “in line with the Co-operation Agreement between PIC/S and [the European Medicines Agency] EMA.”
(RELATED: EU foresees reenergized clinical trial sector as new regulations take effect, Regulatory Focus 27 January 2022)
In 2017, the European Commission released guidelines on GMP requirements for investigational medicinal products in line with the CTR that became applicable when the new regulation entered into effect this week.
Keeping the PIC/S and EU GMP guides harmonized supports “the aim of keeping GMP standards equivalent thus facilitating the exchange and use of information concerning the manufacture of medicinal products.”
PIC/S also announced the introduction of a new Annex 16 on certification by authorized persons and batch release. The group said that the annex had not been adapted to the PIC/S GMP guide as it was considered “to be EU-specific and difficult to transpose.” Last June, PIC/S set out to adapt the annex for the first time. (RELATED: PIC/S looks to adopt EU Annex on qualified persons, batch release, Regulatory Focus 16 June 2021)
However, a consultation in 2017 found that the adaptation of the annex “could offer added benefit to better convey expectations associated with product release and further international harmonisation efforts.” PIC/S notes that the “elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.”
Both Annexes were approved by the PIC/S Committee last week, following the drafting and revision by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, and entered into force on 1 February 2022. The group encourages non-European Economic Area authorities and PIC/S applicants to transpose the annexes into their own guidelines.


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