PIC/S Hits European Commission over Relaxed ATMP GMPs

An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products.

New proposed EC rules lowering GMP standards for ATMPs increase liabilities for drug regulators, according to a letter from the Pharmaceutical Inspection Co-operation Scheme.

The lower standards may lead to confusing variations between the EU’s GMP guidelines and those of the PIC/S Committee, which includes bodies such as FDA, Health Canada and Swissmedic.