Mexico Issues Guidance on Compliance with Global Drug Reporting Standards

Mexico’s drug regulatory agency, COFEPRIS, has released new guidance on pharmacovigilance reporting procedures in line with international standards. The guidance outlines the approval process for new drugs and includes requirements for reporting adverse reactions.

Mexico is a member of the WHO’s Program for International Drug Monitoring, which includes more than125 member countries.

The program’s VigiBase contains more than 10 million reports of adverse drug reactions. The new guidance places Mexico among countries whose regulations are “harmonized with best practices worldwide,” COFEPRIS said.