COFEPRIS, the decentralized division of the Department of Health in Mexico, is the governing body for medical devices and medicines. COFEPRIS has officially joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which bridges the most important regulatory agencies in the world.
COFEPRIS plans on promoting regulatory policy that guarantees access of better health solutions to its local population. The Agency will be proposing initiatives to strengthen clinical research, requirements for medical devices, innovative medicines, generics and biotechnology.
The Federal Commissioner for Protection against Sanitary Risks, Julio Sanchez -Tepoz, stated, “the institution will continue working to strengthen timely access to safe and effective products of the highest quality at the best prices. We will implement strategies that protect the population against health risks, promote economic activity and combat illegal products and services that do not comply with health regulations.”
What else is on COFEPRIS’s 2018 Agenda?
- Chair, coordination group of the National Regulatory Agencies of Regional Reference (rRNA) in the Americas. The objective is to advance regulatory harmonization in the Americas (Argentina, Brazil, Canada, Colombia, Cuba, Chile, and the United States).
- Release regulatory guidance for generic and innovative medicines. Consolidate NOM-257, Regulations for Biotechnology Medicines.
- Regulation of cannabis-derived products for therapeutic use.
- Close gap in scientific knowledge of medical issues. COFEPRIS will be offering its first digital course in health sciences in collaboration with University of California, Berkeley.
- Operation of new authorized third parties for health surveillance tasks.
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