Increasing oversight of API manufacturing through international collaboration

The European Medicines Agency and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today.

This international collaboration allows EMA, several European Union national authorities (France, Denmark, Ireland, Italy, and the UK), the European Directorate for the Quality of Medicines (EDQM), the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada , the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on good manufacturing practice (GMP) inspections of manufacturers of APIs that are located outside the participating countries.

Increased out-sourcing around the world