EMA collaboration on oversight of API makers

Generics/General | Posted 11/05/2018 post-comment0 Post your comment

The European Medicines Agency (EMA) announced on 12 April 2018 that it had published the International API inspection programme report for 2011−2016.

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The 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), Japan’s 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.

The initiative started with a pilot programme aimed at increasing international cooperation in the field of GMP inspection, which was conducted between 2008 and 2010. It became a full programme in January 2011. WHO joined the programme as an observer in January 2012. Then Health Canada and the PMDA also joined as observers in 2016. All three became full members in 2016 [1].

This report gives an overview of the activities carried out by European authorities, FDA, the TGA and WHO between 2011 and 2016. Over these 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%).

The data show that there was an increase in the number of active pharmaceutical ingredient (API) sites inspected by participating authorities included in the programme and this increase has supported the exchange of information on inspections which in return supported a better GMP oversight for the participating authorities.

Based on the conclusions of the report, the participating authorities recommended that the collaboration on API inspections be continued. They also recommended that a formal, central repository be established and that the participants should establish clear deliverables to be assessed at regular intervals within the programme.

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1.  GaBI Online - Generics and Biosimilars Initiative. Japan joins international GMP collaboration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 11]. Available from: www.gabionline.net/Policies-Legislation/Japan-joins-international-GMP-collaboration

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Source: EMA

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