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WHO joins forces with EMA and FDA on pharma manufacturing investigations

International collaboration will focus on sharing information on inspections of API manufacturers that are located outside the participating countries

The World Health Organization (WHO) has joined international regulatory bodies in a global collaboration on manufacturing practice inspections.

The WHO will team up with the European Medicines Agency, the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) to develop joint efforts to improve practices at drug manufacturing facilities.

EU Member States and the European Directorate of the Quality of Medicines and Healthcare (EDQM) are also involved in the partnership.

Together, the organisations aim to "share information on inspections, including planning, policy and reports, for manufacturers of active pharmaceutical ingredients (APIs) that are located outside the participating countries". Joint inspections between organisations will also take place.

The WHO's involvement is part of its Prequalification of Medicines Programme, which aims to provide good quality medicines for everyone, with a focus on medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health in developing nations.

Previously the WHO has evaluated the quality, safety and efficacy of medicinal products on its own, based on information submitted by the manufacturers and inspection of the manufacturing and clinical sites, but it will now work more closely with national and regional drug regulators.

The WHO's involvement expands an international pilot on collaboration on good manufacturing practice (GMP) inspections of API manufacturers that was conducted between December 2008 and December 2010.

This involved the EMA, the FDA and the TGA working to develop co-operative efforts and "mutual confidence" through improved communication and better exchange of information.

During the pilot, the agencies shared 250 documents relating to 54 different medicines and organised 13 collaborative inspections of clinical trials, leading to an announcement in August 2011 from the EMA and FDA that they would continue their co-operative efforts.

The project is also being expanded to include additional international partners that adhered to guidelines described in terms of reference published by the existing partners.

7th March 2012

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