On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in Acapulco, Mexico, for a Summit of Health Authorities.
The topics of the agenda were regulation harmonization, reduction of transaction costs, and facilitation of access to drug products and vaccines of high quality and low cost.
The Health Authorities certified as of Regional Reference currently are those of Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Brazil (ANVISA) and Cuba (CECMED). During the meeting, the representatives of FDA and Health Canada announced their decision to seek the PAHO certification for their own institutions.
The recognition will follow an evaluation of the agencies’ performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in their countries. For more information on the System for Evaluation of the National Regulatory Authorities for Medicines, please refer to the PAHO website.
The regulatory agencies agreed to work together on three main tenants in 2014:
- Strengthening of the regulatory capacity of the group: exchange of site inspection and drug product reports to avoid duplicate work, acceleration of marketing authorization approval for drug products, and reduction of barriers for new molecules to enter the markets, with the aim of reducing costs.
- Increase of technical cooperation to support other agencies in the region and invite other countries to be observers of the group.
- Design and implementation of a communication strategy for all involved parties to stay current on the progress of the consolidation of the Health Authorities network.
The agreements were signed by Mikel Arriola (Mexico), Rafael Pérez Cristiá (Cuba), Carlos Alberto Chiale (Argentina), Ana Paula Soares (Brazil), Blanca Elvira Cajigas (Colombia), Howard Sklamberg (USA) and Cathy Parker (Canada).
The next meeting of the group will take place next September in Washington, DC.