Mexico Amends API Manufacturing Regulations to Meet EU Requirements
Mexico's Ministry of Health, through the Federal Commission for Protection against Health Risks (COFEPRIS), has updated the country's requirements on Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients (APIs) comparable to those issued by the European Union.
The new GMP requirements come into force immediately and are mandatory for all establishments engaged in the manufacture and distribution of APIs.
With this standard, Mexico believes that it has met the requirement for API exports to the EU under the EU Falsified Medicines Directive, which comes into force on 2 July 2013.