Increasing oversight of API manufacturing through international collaboration

News 12/04/2018

Report on the International API inspection programme published

The European Medicines Agency (EMA) 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 PDF icon International API inspection programme report for 2011-2016 , published today. APIs are the substances responsible for the activity of a medicine.

This international collaboration allows EMA, several European Union national authorities (France, Denmark, Ireland, Italy, and the United Kingdom), the European Directorate for the Quality of Medicines (EDQM), the United States 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.

Nowadays, many pharmaceutical companies outsource the production of APIs to contract manufacturers located all over the world. This has led to an increased need for inspections, to ensure adequate oversight of these facilities. The overall objective of this initiative is to ensure more sites are monitored by making best use of inspection resources worldwide through increased cooperation, mutual reliance between participating regulatory bodies, reducing duplication of inspections and increasing inspection coverage.

The initiative started with a pilot in 2008-2010, and became a full programme in January 2011. The report published today gives an overview of the activities carried out by European authorities, the FDA, TGA and WHO between 2011 and 2016. Health Canada and the PMDA only joined at a later stage, therefore the report does not cover information on their activities.

Over six years, 1,333 inspections were carried out at 458 manufacturing sites of common interest. These sites were located in 18 different countries, most of them in India (49%) and China (36%).

During this period, the programme has grown both in membership and sites of common interest. The level of information shared between participants has increased, and overall inspection coverage grew, benefiting global public health. The participating authorities concluded that this programme is beneficial and agreed to continue their collaboration. At the same time, a series of proposals were made to further streamline day-to-day operations, such as improvements of the electronic platforms for information exchange, and also regular reviews of the programme deliverables.

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