Washington DC, 24 June 2021 (PAHO)- The Pan American Health Organization (PAHO) presented to more than 200 representatives of the pharmaceutical industry the Central American Mechanism for the Joint Evaluation of Medicines that seeks to ensure the quality, safety, and effectiveness of medicines and health technologies in the Region.
The mechanism was launched by the National Regulatory Authorities (NRAs) of Costa Rica, El Salvador, Guatemala, and Honduras, with the support of the Pan American Health Organization (PAHO), in October 2019.
While respecting the regulations, processes, and administrative procedures of each participating country, the mechanism ensures a unique technical review that will reduce registration times in the subregion, completing the procedure in less than three months.
"This mechanism will undoubtedly contribute to improving access to quality, safe and effective medicines, and will bring the regulatory authorities closer together to unify the criteria for the application of the Central American Technical Regulations," said Analía Porrás, Chief of the Medicines and Health Technologies Unit at PAHO.
Likewise, the mechanism will allow the global pharmaceutical sector to access the Central American pharmaceutical market, optimizing the processing time, preventing giving different results in the evaluations to the same file, with the same regulatory framework. At the meeting, it was announced that chemical synthesis medicines will be admitted at this stage. However, the goal is to expand the complexity of the products that can be reviewed in this mechanism.
Analía Porrás took the opportunity to congratulate the participating countries and the General Coordination of the mechanism, which in this period corresponds to the Sanitary Regulation Agency of Honduras (ARSA).
PAHO provides support in the technical coordination of the mechanism. The initiative is part of joint efforts of PAHO and countries to improve access to safe, effective, and quality medicines and health technologies in the Central American Region.