API

Health Canada has put all Drug Establishment License (DEL) holders on alert as to their regulatory responsibilities and obligations for maintaining good manufacturing practices (GMP).  In addition to increasing the frequency of planned and unplanned inspections of pharmaceutical manufacturing plants, Health Canada now offers a routinely updated and publicly available online tool for tracking the latest regulatory actions against drug manufacturing companies.  The “Inspection Tracker: Drug Manufacturing Establishments” provides a “snapshot of the potential health and safety issues that Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute, or import drugs for sale in Canada.”   In response to allegations of inadequacy and secrecy, Health Canada has now made available the results of its pharmaceutical manufacturing plant inspections since 2012.

Source:  Toronto Star,  6 March 2015

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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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