Mexico and Brazil Advance Drug Registration Pathway Based on Anvisa
核心洞察
Mexico's COFEPRIS (搜索) can now base medicine registration decisions on Brazil's Anvisa evaluations within 45 business days under guidelines published Sept. 2, 2026.
The pathway takes effect Oct. 15, 2026 and covers new molecules, generics, innovative biotechnological drugs, biocomparables, biologicals and vaccines.
Eligibility excludes conditional, emergency, court-ordered and reliance-based Anvisa approvals, and quality or manufacturing site changes revert applications to the ordinary procedure.
Mexico has established an abbreviated registration pathway that allows its Federal Commission for the Protection against Sanitary Risks (COFEPRIS (搜索)) to rely on prior assessments and decisions by Brazil's National Health Surveillance Agency (Anvisa) instead of repeating the full technical evaluation. Decisions are to be issued within 45 business days. Mexico's Ministry of Health published the general guidelines in the Official Gazette of the Federation on Sept. 2, 2026, with the pathway taking effect Oct. 15, 2026.
The guidelines apply only to medicines, covering new molecules, generics, innovative biotechnological drugs, biocomparables, and biologicals and vaccines. Eligibility is limited: the product must have essential characteristics identical to those authorized in Brazil, while conditional, emergency, court-ordered, and reliance-based Anvisa approvals are excluded. Changes to quality aspects or manufacturing sites return the application to the ordinary procedure. The instrument brings in an agency that had remained outside Mexico's reliance scheme because it is not a WHO-Listed Authority.
Cooperation between the two regulators predates the measure. Since 2025, COFEPRIS (搜索) has treated Anvisa as a reference authority for medical device registration and inspection, in addition to existing recognition in medicine inspections, and the agencies signed a new memorandum of understanding in August 2025 alongside a separate agreement on medicine and vaccine production. The bilateral agenda discussed by Brazilian Health Minister Alexandre Padilha and Mexican Health Minister David Kershenobich also covers local production, technology transfer, medicine supply, primary care, workforce training, and research, with a proposed bilateral committee on artificial intelligence in health. The Brazilian delegation's agenda concludes on Sept. 23 with presentation of the Brazil-Mexico Work Plan 2026-2027, Anvisa-COFEPRIS regulatory cooperation, and an mRNA vaccine collaboration between the Oswaldo Cruz Foundation (Fiocruz (搜索)) and Mexico's state-owned Laboratories of Biologicals and Reagents (BIRMEX (搜索)).