Regional cooperation between drug regulatory agencies strengthens as Argentina and Mexico sign an agreement to standardize procedures
Chile
26 septiembre 2018

On September 14th, Argentina’s National Administration of Medicines, Food and Medical Technology (ANMAT) and Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) signed an agreement to facilitate the exchange of inspection reports in the pharmaceutical industry. This achievement strengthens the process of standardization initiated with a commitment made by the national regulatory authorities in 2012, which already involves Argentina, Brazil, Chile, Colombia and Mexico. The agreement is expected to simplify and expedite the issuance of health records.

The agreement establishes a unified mechanism to validate inspections that verify compliance with Good Manufacturing Practices (GMP) in labs located in Argentina and Mexico. The implementation is framed in turn in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) integrated by the two agencies. Following the incorporation of COFEPRIS in January this year, Mexico and Argentina are the only two members in the region.

In July, Argentina’s agency ANMAT announced the signing of an agreement of similar scope with Colombia’s National Institute of Surveillance of Medicines and Foods (INVIMA) and in September another one with Chile for the standardization of drugs evaluation procedures. These are not the only achievements at the regional level. In May, Brazil’s National Health Surveillance Agency (ANVISA) certified the GMPs of two Colombian laboratories based on INVIMA’s records, implying that the controls of the Colombian entity were equivalent to those that could be applied from Brazil.

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