An international program for the inspection of sterile drug manufacturers is underway

The European Medicines Agency (EMA), together with European and international partners, is launching a pilot program to enhance cooperation in the field of inspections of sterile drug manufacturers for human use. This new initiative is a result of success and experience gained from a similar collaboration within the International Active Pharmaceutical Ingredient Verification Program(API).

This collaboration will enable EMA and national regulatory authorities in Europe (France and the UK), as well as the US Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA), Health Canada, the Japan Pharmaceuticals and Medical Devices Agency (PMDA), the World Health Organization (WHO) to share information on compliance audits for the Good Manufacturing Practice (GMP) by manufacturers of sterile medicines outside the participating countries and organize joint inspections for production facilities of common interest.

The international cooperation in inspection has already demonstrated some benefits in improving manufacturers supervision and making the best use of inspection resources worldwide through mutual exchange between participating regulatory bodies, reducing inspection overlaps and increasing the coverage of production facilities being inspected throughout the world.

The products covered by this programme are sterile drugs for human use of chemical origin and certain products derived from biotechnology (such as monoclonal antibodies and recombinant proteins). Products not currently covered by the “pilot” include vaccines, cellular and gene therapy products, as well as preparations derived from blood plasma.

The pilot program will last for a minimum of two years, thereafter the participating bodies will evaluate it and determine the next steps in the cooperation.