Mexico acknowledges Anvisa's regulatory decisions and establishes a simplified procedure for drug registration
Cooperation between the two agencies has been developed for over two decades
Mexico has established a simplified regulatory procedure for drug registration based on decisions by the Brazilian Health Regulatory Agency (Anvisa). Under the new guidelines, the Federal Commission for Protection against Health Risks (Cofepris) now recognizes the requirements, tests, and evaluation procedures conducted by the Brazilian health authority as equivalent. This allows medicines that have already been evaluated and approved by Anvisa to undergo a faster procedure for obtaining a health registration in Mexico.
The decision applies to drugs containing new molecules, generics, innovative biotechnological drugs, biosimilars, as well as biological products and vaccines. To undergo this procedure, the product submitted in Mexico must have essential characteristics identical to those authorized by Anvisa, and the Brazilian authorization must be currently valid. The required legal, technical, and scientific documentation must also be submitted to the Mexican authority.
According to Anvisa’s CEO Leandro Safatle, the decision is a milestone in the Agency's international operations. "Mexico has decided to accept Anvisa registrations, something that has never occurred before. This is one of the greatest advances in Brazilian health diplomacy and shows the trust built in the quality and technical capacity of our regulatory system," he states. Cooperation between Anvisa and Cofepris has been developed for over two decades and includes memoranda of understanding, information exchange, and initiatives related to good manufacturing practices and regulatory convergence.
Under the simplified procedure, Cofepris will be able to leverage the assessment previously conducted by Anvisa, avoiding the repetition of analyses, since they have already been completed. The document establishes that, once all required documentation is complete and properly filled out, there will be no need for a new technical review of aspects already evaluated by the Brazilian agency. The maximum timeframe set for the Mexican authority's decision is 45 business days.
“We are changing regulatory trust into access and integration. A process that could take years may now be completed within 45 business days, while assuring quality, safety, and efficacy. This recognition sets an important precedent for expanding cooperation among the region's health authorities and advancing the construction of a regional health sovereignty,” highlights Safatle. The agreement with Mexico underscores that regulatory recognition and reliance mechanisms allow for the reduction of double assessments, the optimization of public resources, and the improve timely public access to medicines, however preserving Cofepris's autonomy regarding decisions made in Mexico.