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U.S. Department of Health and Human Services

International Programs

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Program to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers

FDA, TGA, EMA, edqm, Council of Europe Logos


New Terms of Reference in connection with the ongoing international collaboration on GMP inspections of active substance manufacturers are published today.

The Terms of Reference include pre-requisites for the inclusion of new partners. This has enabled the WHO to become a new partner in connection with its Prequalification of Medicines Program. This is the first step of the expansion of the international program which fosters cooperation and sharing of resources between regulators for a better inspectional coverage of active substance manufacturers worldwide and contributes to the realization of the WHO objective of safe and effective medicines for all.

PdfIcon New Terms of Reference [300 KB]

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