DDReg Pharma- Consulting in regulatory affairs and drug safety

Mexico’s regulatory environment for pharmaceuticals and medical devices is complex and crucial for public health and safety. The country has developed a robust framework to oversee these sectors, largely driven by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Here are ten crucial insights into regulatory services and pharmacovigilance in Mexico : 1. COFEPRIS: The Regulatory Authority COFEPRIS is the central regulatory body in Mexico responsible for overseeing the safety, efficacy, and quality of pharmaceuticals, medical devices, and other health-related products. This agency operates under the Ministry of Health and is pivotal in implementing national health policies and regulations. 2. Regulatory Framework Mexico’s regulatory framework for pharmaceuticals and medical devices is established through various laws and regulations, including the General Health Law and its corresponding regulations. These laws outline the requirements for product registration