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EMEA, Health Canada link up

This article was originally published in The Tan Sheet

Executive Summary

The health authorities will share legislation under development, draft guidance documents and non-public safety and efficacy data on regulated products, according to an implementation plan for regulatory cooperation published April 2.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)

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