Exploring Pharmacovigilance Processes in Mexico
The healthcare landscape in Latin America is evolving, with pharmacovigilance becoming a central focus to ensure patient safety and regulatory adherence. Among the key players in the region, Mexico stands out with its proactive approach to monitoring adverse events and aligning with international standards, which is shaping the future of drug safety in the country.
COFEPRIS’ guidelines are based on the Mexican Official Standard NOM-220-SSA1-2016, aligning with the European Medicines Agency’s (EMA) Good Pharmacovigilance Practices (GVP), while also incorporating specific national requirements like the use of VigiFlow for adverse event reporting. This ensures alignment with international standards such as ICH E2B, further strengthening the global pharmacovigilance network.
Pharmacovigilance in Mexico
Pharmacovigilance in Mexico is governed by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the National Pharmacovigilance Centre (CNFV). This framework ensures the quality, safety, and efficacy of medicines marketed within the country. The marketing authorization holders (MAH) are mandated to adhere to stringent pharmacovigilance activities, facilitating a robust drug safety system.
The Mexican pharmacovigilance process encompasses:
- Regulatory guidelines and compliance with COFEPRIS standards.
- Maintenance of a Pharmacovigilance System Master File (PSMF).
- Appointment of a local pharmacovigilance responsible person.
- Compilation and submission of Periodic Risk-Benefit Assessment Reports (PBRERs).
- Systematic monitoring, collection, and reporting of safety data, including literature surveillance.
Key Regulatory Guidelines
COFEPRIS’ guidelines are anchored in Mexican Official Standard NOM-220-SSA1-2016, aligning with EMA’s Good Pharmacovigilance Practices (GVP) while incorporating country-specific requirements such as the use of VigiFlow for adverse event reporting. This ensures compatibility with international standards like ICH E2B, enhancing the global pharmacovigilance network.
Role of Local Pharmacovigilance Contact Person
The MAH must appoint a qualified legal representative in Mexico responsible for managing pharmacovigilance activities which includes-
- Collecting and reporting safety data.
- Coordinating with COFEPRIS and global QPPV.
- Developing and maintaining standard operating procedures (SOPs) approved by the State Pharmacovigilance Centre.
The legal representative must be domiciled in Mexico and possess requisite qualifications, ensuring efficient compliance and safety oversight.
Periodic Risk-Benefit Assessment Report (PBRER)
COFEPRIS typically follows ICH E2C (R2) guidelines for PBRERs but exempts certain products like traditional herbal medicines from routine submissions unless specified. An annual safety report, maintained in alignment with these guidelines, serves as a preparatory document in case of regulatory requests.
Risk Management Plans (RMP)
RMPs must address any identified or potential safety concerns. For herbal products, COFEPRIS may mandate an RMP based on specific safety concerns. Translations of EMA-compliant RMPs, with country-specific risk minimization activities annexed, are acceptable.
Challenges in Pharmacovigilance
Although the regulatory framework is in a state of evolution, following challenges are still present-
- Underreporting of adverse events, particularly for self-administered herbal drugs.
- Difficulties in causality assessment due to concurrent use with other medications.
- Ensuring compliance amid rapid regulatory updates.
A comprehensive understanding of local pharmacovigilance roles and diligent adherence to COFEPRIS guidelines can help mitigate these challenges, safeguarding patient safety and regulatory compliance.
Conclusion
Mexico’s pharmacovigilance landscape reflects a commitment to international safety standards while addressing local nuances. For MAHs, a proactive approach in aligning with these requirements ensures the sustained safety of marketed products and adherence to global best practices.
DDReg brings over 15 years of experience in pharmacovigilance including establishing robust systems to ensure compliant and efficient safety evaluation. Reach out to our experts for end-to-end pharmacovigilance services: Read more from our experts global PV experts: Identifying Barriers in Reporting Medical Device Adverse Effects https://regic.net/
