Regulatory Certainty Strategy for the pharmaceutical sector
- Jan 20, 2023
- 1 min read
On January 16, 2023, COFEPRIS released through its website the document called Regulatory Certainty Strategy for the pharmaceutical sector.
Content of the document (first part)
Objective: to provide certainty to companies in the pharmaceutical sector that offer medical innovations and productive development. Strategy: COFEPRIS work agenda 2022-2030 Context. Take advantage of the potential of Mexico. According to ECLAC (Economic Commission for Latin America and the Caribbean), a long-term horizon is required, regulatory measures will be developed and implemented to reduce technical barriers. Regulatory certainty: Regulatory compliance with clarity in requirements, evaluation processes, and associated times. Ensure standardized evaluation, based on technical-scientific criteria. Effective recognition of decisions of other regulatory agencies. Regulator-regulated interaction without corruption and without conflict of interest, favoring governance. Regulatory changes with a vision of improvement, harmonization, and regulatory innovation to achieve a stable regulatory system, with governance mechanisms, adequate implementation times, and a long-term vision.
Guiding Principles: 1. National Development Plan 2019-2024 and Health Sector Program 2020-2024, contemplate administrative simplification and regulatory improvement, guarantee the supply of medicines in the country and where the market does not replace the State 2. Consider the International Treaties to which Mexico is a party; memberships aimed at the regulatory harmonization of products for human use; the Good Regulatory Practices (GRPs) of the WHO and the WHO criteria of the Global Benchmarking Tool for Evaluation of National Regulatory Systems of Medicines and Vaccines (GBT) 3. Compliance with the Health Self-Sufficiency Plan developed by ECLAC
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