On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
The Federal Commission for Protection against Health Risks (COFEPRIS) and the Food and Drug Administration of the United States (FDA) held the first high-level meeting of 2023, in which they agreed on the implementation plan for this year to guarantee the safety, quality and efficacy of medicines, as well as food safety for the benefit of the health of the populations of both nations.
COFEPRIS 2022 Improvements
- The head of COFEPRIS, Alejandro Svarch Pérez, presented to the U.S. delegation, led by the director of the FDA’s Latin American Office, Katherine Serrano, the progress made by this commission during 2022 in different areas; for example, in terms of health surveillance, the Mexican regulatory agency closed 79 irregular surgical clinics for the first time and imposed a total of 23 million Mexican pesos in fines.
- Regarding the New Strategy for Liaison with the Regulated Industry, established by the federal commissioner of COFEPRIS, which consists of a more direct relationship with representatives of the different sectors, the result was the implementation of EducaPris, which records more than 70 sessions transmitted live.
COFPERIS Regulatory Priorities
Likewise, the meeting shared the three priorities of the Mexican health agency for 2023, which are in the areas of:
- Pharmaceuticals (medicines), and
- Medical devices.
Areas of Collaboration
- The areas where collaboration will be deepened between the two agencies will be : medical devices, where the aim is to align regulatory frameworks and participate in the International Medical Device Regulators Forum (IMDRF); and the Medical Device Audit Program (MDSAP).
- In the area of medicines, the support in the implementation of the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue.
- These activities will promote the implementation of recognition mechanisms that increase access to safe, quality medical products and strengthen the supply chain for the benefit of thousands of patients.
- In addition, the analysis of genomic sequences of pathogens isolated from food will be enhanced; training in traceability in cases of outbreaks to strengthen collaboration in the attention of those related to priority products; as well as training in the safety of agri-food products.
Learn more about Cofepris and FDA
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