Federal Commission for the Protection Against Health Risks (COFEPRIS) - COFEPRIS issues updated Good Manufacturing Practice (GMP) guidelines

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2025

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ELSIBI

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OpenEdition

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info:eu-repo/semantics/openAccess

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Mexico’s COFEPRIS has issued GMP guidelines (N.B. this webpage can be translated from Spanish). These guidelines aim to facilitate the recognition of international regulations and reduce administrative barriers for the pharmaceutical industry. Under the new guidelines, Mexico will: accept GMP certifications issued by regulatory agencies in Brazil, Argentina, Canada, Colombia, Chile, Cuba and the US, implement the full digitization of processes, align with the international Pharmaceutical Inspection...

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