Europe – Euro Regulatory Roundup

The European Medicines Agency (EMA) has changed its joint audit program guidance to permit the involvement of its international peers as co-auditors. The revised guidance gives regulatory agencies with mutual recognition agreements (MRAs) with EMA the chance to take part in audits of the good manufacturing practice (GMP) inspectorates of national authorities.

Working with EMA, the Heads of Medicines Agencies (HMA) set up the audit program to monitor the implementation and equivalence of GMP inspectorates in the European Economic Area. Through the program, EMA and HMA seek to satisfy the requirements of MRAs with overseas regulatory agencies and maintain confidence in the GMP compliance systems used in Europe. Those elements make the joint audit program part of the reason foreign regulators trust GMP reports from European agencies.

Despite the significance of the program for the functioning of MRAs, EMA’s foreign partners have historically had limited direct involvement in the audits. The guidance adopted by EMA and HMA last year on the subject set out the rules on observers of audits but lacked provisions for MRA partners to take a more active role in the process…