To make best use of its limited resources, the Institute of Medicine (IOM) concludes that the US Food and Drug Administration (FDA) should direct resources to improve the regulatory systems of developing nations to better ensure the safety of the global pharmaceutical supply chain.  Rather than try to inspect all foreign establishments itself, the FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand are encouraged to plan a system for mutual recognition of inspections, which would eliminate the wasteful duplication of effort.  Along these lines, an active pharmaceutical ingredient (API) inspection program involving many of the world’s premiere global regulatory bodies (FDA, the European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the European Directorate for the Quality of Medicines & Healthcare (EDQM), and the Council of Europe (CE)) has formed to facilitate international collaboration and information sharing to enhance inspection capacity.   Since data review and interpretation is already being shared between some global regulatory authorities in the nonclinical safety arena, it will be interesting to see if such global harmonization efforts extend to nonclinical safety inspections in the near future.

 

Sources: 

RAPS – Regulatory Focus:  IOM – Boost Foreign Regulatory Capacity and  Global API Inspection Scheme

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