The PAHO/WHO revalidated the certification of Mexico´s Federal Commission for the Protection against Sanitary Risks as a National Regulatory Authority (ARN'S) for medicines with Level IV, through the delivery of the corresponding document by the representative in Mexico of that international organization, Dr. Jerry Eikemans, to the Minister of Health, Dr. José Narro Robles.
The process of evaluation and qualification of the ARNs is based on the verification of indicators and compliance with recommendations of the World Health Organization, which makes the regulatory agencies competent and efficient to ensure the efficacy, safety and quality of medicines.
At the ceremony, was also announced the income of the Federal Commission for Protection against Sanitary Risks (COFEPRIS) to the Pharmaceutical Inspection Cooperation Scheme (PIC/S), an organization that brings together the most important regulatory agencies in the world.
The entry of COFEPRIS into PIC/S is an international recognition of the tasks of health regulation, designed, implemented and monitored through COFEPRIS, which comply with international parameters to improve public health.
In this regard, the Secretary of Health, José Narro Robles, stressed that the adhesion of COFEPRIS to PIC/S translates into quality, safety, good practices, access and availability of pharmaceutical products.
For his part, the commissioner of COFEPRIS, Julio Sánchez, explained that the dependency under his charge assumed the commitment to align the regulatory processes related to the standards established by PIC / S, through an intense institutional work for the development, implementation and maintenance of actions to comply with international guidelines on the matter.
Benefits:
- International harmonization of Good Manufacturing Practices (GMP) allowing participation in the development / updating of international guidelines.
- Training opportunities: Seminars, joint inspection visits.
- Exchange of information and fast alert system among participating agencies.
- Facilitation of the negotiation of instruments for recognition of GMP certification between the member agencies.
Benefits of COFEPRIS recertification by OPS
- Greater participation in the implementation of consultation and feedback mechanisms among the NRAs that allow the sharing of information and optimize the decision-making on registries, GMP certifications, clinical trials, bioavailability, bioequivalence and pharmacovigilance.
- Support the strengthening and strategic development of the Pan American Network for the Harmonization of Pharmaceutical Regulation (Red PARF).
- Support regional mechanisms for the procurement of medicines (Revolving Funds of PAHO) so that they are mainly based on the installed capacities of rRNA.
- Cooperate with PAHO in the prioritization of training needs for the strengthening of regulatory processes, and in the development of a regional strategy to respond to these needs.
- Mexico promotes increased access to a greater number of therapeutic options through medicines and biological products are safe, quality and effective.
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