Overview
This blog details the recent agreement signed between the Federal Commission for Protection against Sanitary Risks (COFEPRIS) and the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (CCINSHAE). The primary objective is to optimize the detection of adverse reactions and medical device incidents within the most complex health institutions in the country.
Introduction
In the landscape of Mexican public health, post-market surveillance is the pillar that ensures medicines and medical technologies maintain a favorable benefit-risk profile. Recently, COFEPRIS took a historic step by formalizing a collaboration agreement with CCINSHAE. This alliance is not merely an administrative procedure, but a technical commitment to safeguard the safety of patients using high-specialty services in Mexico, integrating sanitary surveillance directly at the point of patient care.
Scope of the Agreement
The agreement establishes a framework for technical cooperation regarding information exchange and continuous training. CCINSHAE, which coordinates reference hospitals and national institutes, will function as an advanced sensory arm for COFEPRIS.
Strengthening Pharmacovigilance
Pharmacovigilance in Mexico is governed by the standard NOM-220-SSA1-2016. With this agreement, the goal is to:
- Accelerate Reporting: Facilitate the notification of Suspected Adverse Drug Reactions (SRAM).
- Data Quality: Improve the technical precision of reports generated in high-specialty hospitals.
- Monitoring of Biosimilars and Innovators: Ensure rigorous monitoring of complex therapies.
Advancements in Tecnovigilance
Regarding medical devices (NOM-240-SSA1-2012), tecnovigilance receives a new boost. This collaboration will allow for:
- Early identification of adverse incidents with life-support and diagnostic medical equipment.
- Implementation of corrective safety actions more swiftly across the national territory.
- Creation of expert networks to evaluate the performance of technologies in real clinical settings.
The Role of Digitalization
COFEPRIS emphasized that this union aligns with its digitalization strategy, aiming for information flows between institutions and the sanitary authority to be more efficient, transparent, and free from unnecessary bureaucracy.
Conclusion
The signing of this agreement between COFEPRIS and CCINSHAE marks a turning point in Mexican sanitary regulation. By uniting normative authority with clinical excellence, Mexico positions itself as a regional leader in sanitary safety. For the pharmaceutical and medical device sectors, this movement signals the need for increasingly rigorous compliance, while for citizens, it represents a guarantee that the health system is vigilant and constantly evolving to protect their lives.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about.
COFEPRIS. “COFEPRIS y CCINSHAE firman convenio para fortalecer farmacovigilancia y tecnovigilancia”. Press Release, Government of Mexico.
Official Mexican Standard NOM-220-SSA1-2016, Installation and operation of pharmacovigilance.
Official Mexican Standard NOM-240-SSA1-2012, Installation and operation of tecnovigilance.
CCINSHAE. Institutional Programs and Patient Safety in High Specialty Hospitals.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.
