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Mutual recognition of GMP inspections:...

Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory...

Mutual recognition of GMP inspections: how international agreements work

Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory authorities to rely on defined elements of one another’s Good Manufacturing Practice (GMP) inspection systems. By reducing unnecessary duplication of inspections and, where applicable, batch testing, these agreements support international regulatory cooperation while maintaining oversight of medicinal product quality. However, mutual recognition is conditional. Its scope depends on the legal framework, the authorities involved, the products covered, the types of inspections concerned and the territorial provisions of each agreement. GMP inspection cooperation and mutual recognition Pharmaceutical manufacturers supplying several international markets may be subject...

Mutual recognition of...

Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory authorities to rely on defined elements of one another’s Good Manufacturing Practice (GMP) inspection systems. By reducing...
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