Regulators Launch International Sterile Medicines Inspection Pilot
The European Medicines Agency (EMA) on Tuesday announced the launch of a two-year pilot that will allow regulators across the EU, US, UK, Australia and Canada to share information from good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.Specifically, the pilot will enable information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and allow participants to organize joint inspections.
The pilot, which EMA says will last for a minimum of two years, will include EMA, the US Food and Drug Administration, the UK’s Medicines and Healthcare products Regulatory Authority, France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé , Australia’s Therapeutic Goods Administration , Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency and the World Health Organization.
EMA says the pilot is modeled after an earlier joint inspection program for active pharmaceutical ingredients (APIs), which was piloted in 2008 and fully implemented in 2012.
“The benefits of international collaboration in the inspection of manufacturers of active pharmaceutical ingredients have been demonstrated over a number of years. More efficient use of international inspectional resources facilitates broader inspectional coverage and allows risk-based inspection planning, thereby benefiting public health and patients by focusing on sites of highest identified risk,” EMA writes.
Under the pilot program, participants are committed to coordinating and sharing their inspection plans with other participating authorities, conducting inspections according to predefined GMP requirements, sharing inspection outcomes with other participants on a monthly basis and providing inspection reports to other participants as requested.
The pilot also encourages participants to coordinate joint inspections rather than sole or concurrent inspections.
While the pilot is geared toward routine surveillance inspections of previously inspected sites, EMA says that participants can include for-cause and pre-approval inspections at their own discretion.
EMA notes that the pilot will apply to human drugs and certain therapeutic biologics, such as monoclonal antibodies and recombinant proteins, but excludes vaccines, cell and gene therapies and plasma-derived products.
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