The EC mooted separate manufacturing guidelines for advanced therapy medicinal products (ATMP) in 2015 when it suggested the variability of gene therapy, cell therapy or engineered tissues relative to small molecule drugs may require specific rules.
In September the EC published draft guidelines for consultation.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) provided its feedback in a letter published last week, raising concerns the plan will put patients at risk and damage international harmonization efforts.
“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 – which represents regulators which oversee the safety of drugs in multiple markets worldwide – also suggested separate ATMP GMP guidelines will undermine long-term efforts to align GMP guidelines.
“Since 1989, both [PIC/S GMP and EU GMP] 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.”
This echoes worries expressed by the Alliance for Regenerative Medicine (ARM) last year.
At the time the organisation – which counts cell and gene therapy developers among its members – said “the creation of a stand-alone document may lead to disparities in GMP standards, creating unnecessary confusion for companies with ATMP and non-ATMP product portfolios.”
The final guidance is expected to be released next year, and the full history of the EC’s initiative can be found here.