Mexico Profile Updated in ClinRegs
January 10, 2020
The Mexico profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include:
- Revised 2019 version of Pharmacovigilance Guide for Safety Notifications or Any Safety Problem Related to the Use of Medicines and Vaccines, which provides instructions on electronically submitting drug safety reports to COFEPRIS’s National Pharmacovigilance Center using its new reporting system, Vigiflow (See the Safety Reporting section)
- New laws/regulations on data protection, including the following: Federal Law on Protection of Personal Data Held by Private Parties, Regulations to the Federal Law on the Protection of Personal Data held by Private Parties, and General Law of Protection of Personal Data Held by Obliged Subjects (See the Definition of Sponsor, Quality, Data & Records Management, Documentation Requirements, Participant Rights, and Children/Minors sections)