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News about GMP/cGMP


PIC/S criticizes stand-alone ATMP GMP Guidelines of the European Commission

In a letter to the European Commission that was published this week, PIC/S (The Pharma Inspection Co-operation Scheme) strongly criticized the Commission’s development of its proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines.


The PIC/S Committee, which comprises representatives of 49 participating authorities, e.g. the US FDA, Health Canada, Swissmedic, the Japanese PDMA, expressed its concerns that these GMP Guidelines will not only lower GMP standards for ATMP at the risk of patients but also lead to an internationally non harmonised approach to the implementation of GMP for ATMP. For PIC/S this could lead to further serious consequences:

The PIC/S Committee is also concerned that due to the European Commission’s initiative in the field of ATMP, the PIC/S GMP Guide and the EU GMP Guide will no longer be equivalent. Since 1989, both Guides have been developed in parallel and systematically kept aligned on the basis of a harmonised consultation procedure, which PIC/S and the EMA have duly and respectfully implemented. Your decision to amend Annex 2 and repeal Annex 13 of the EU GMP Guide is a serious setback in terms of co-operation between the EU and PIC/S. It is very unfortunate that under your leadership the process of GMP harmonisation between the EU and PIC/S GMP Guides has resulted in a divergence that may be difficult to reconcile in the future. We deeply regret the lack of consultation in this matter,” it is stated in the letter of PIC/S Chairman Paul Hargreaves (British MHRA) and his Deputy Boon Meow Hoe (HAS Singapore).

For transparency reasons and for patient safety the PIC/S has published the letter on its website.

For additional information:

Here you will find a list of all comments to the ATMP GMP Guidelines.

A 4-page outcome summary of the European Commission aggregates all comments. According to the EC, 53 contributions to the public consultation were received. The approach described  in  the  Consultation  Document  was supported  by  the  majority  of  the respondents.  Support was particularly strong among academia and SMEs.  However,  a  significant  number  of  submissions  considered  that  further  adaptations  to  the specific  characteristics  of  ATMPs  were still required. Click here to read the outcome document.


PIC/S: Letter to the European Commission

PIC/S: News

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