Pilot Takes Off For Inspecting API Manufacturers By U.S., Europe, Australia
This article was originally published in The Tan Sheet
Executive Summary
FDA and its counterparts in the European Union and Australia have divided responsibilities for inspecting specific active pharmaceutical ingredient facilities in third-country locations in the next 18 months as part of a pilot to monitor more sites
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An initiative by FDA and the European Medicines Agency to share duties related to oversight of clinical trials may also reduce the resource burden on sponsors
EMEA, Health Canada link up
The health authorities will share legislation under development, draft guidance documents and non-public safety and efficacy data on regulated products, according to an implementation plan for regulatory cooperation published April 2. The European Medicines Agency and Health Canada also call for routine communication about good manufacturing practice inspections performed outside the respective territories and will allow access to each other's GMP database information. The cooperation plan says the partnership will seek to include U.S. FDA in joint activities "to minimize duplication of effort." EMEA, FDA and Australia's Therapeutic Goods Administration have launched a pilot to share GMP inspection information (1"The Tan Sheet" Jan. 19, 2009, p. 9)