13/14 December 2022
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products ( e.g. "European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation" and "GMP for ATMP - two Public Rounds of consultation and still a Need for Discussion?") and the ongoing discussion between the authorities, developers of ATMPs, manufacturers and other ATMP related organisations.
On 24 February, the PHARMACEUTICAL INSPECTION CONVENTION/PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/s) has sent a public letter to the European Commission. In this letter they regret that the new document would lead to an internationally non-harmonised approach to the implementation of GMP for ATMP and that lower GMP standards for ATMPs would mean risking patient safety. For reasons of transparency they published the letter on the PIC/S website - stating:
"...The PIC/S Committee is unanimously concerned about the impact on public health and for the safety of patients that the ATMP GMP Guideline will cause. By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk to their health; it is also engaging its individual and collective responsibility for any health incident (and related court action) that lower ATMP standards may occasion. We would like you to duly ponder this aspect.
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......"
The complete letter can be found on the PIC/S website under " PIC/S takes strong stance on European Commission's proposed stand-alone ATMP GMP Guidelines".