Mexico’s Modernized GMP Guidelines: Advancing Pharmaceutical Regulation
On March 20, 2025, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) implemented revisions to its Good Manufacturing Practice (GMP) guidelines to align with international regulatory standards and enhance global recognition. These updates are designed to optimize compliance processes, reduce administrative burdens, and strengthen the efficiency and competitiveness of Mexico’s pharmaceutical sector in the global market.
Mexico’s COFEPRIS Enhances New Molecules Committee to Accelerate Pharmaceutical Innovation
Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has strengthened the expertise of its New Molecules Committee, a key regulatory body responsible for evaluating novel pharmaceutical agents. This initiative aims to enhance evidence-based decision-making, expedite drug approval processes, and expand public access to cutting-edge treatments. By integrating specialized experts, COFEPRIS seeks to streamline regulatory reviews and reinforce Mexico’s role as a leading hub for pharmaceutical research and innovation.
“The inclusion of these specialists will significantly enhance evidence-based decision-making with the highest scientific rigor,” stated COFEPRIS Commissioner Armida Zúñiga Estrada in a 14 March announcement. Furthermore, their work will have a direct impact on the availability of innovative treatments.
Mexico’s Patent Office, COFEPRIS Sign Agreement on Drug Patents
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Mexican Ministry of Health Advances with SaMD
The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).
Registration holder for Medical Devices Imported from Mexico
Registration holder for Medical Devices Imported from Mexico.
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
Mexico’s Cofepris has Issued New Guidelines for Changes to Medical Device Registrations
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
Mexico’s COFEPIRS Pilot program on Technical Sessions
On March 31, 2022, Mexico’s Health Authority COFEPRIS introduced a pilot program that will allow the pharmaceutical and medical device sectors to ask for regulatory guidance in a technical session concerning a variety of topics and will be held by COFEPRIS experts.
MEXICO’S COFEPRIS ANNOUNCES THAT THE INTERNAL AFFAIRS OFFICE WILL BEGIN OPERATION TO COMBAT CORRUPTION
On February 27, 2022, Cofepris, Mexico Health Authority, announced that the internal affairs office will start is operations in combating corruption.
Mexico’s Cofepris Modifies Pharmacovigilance Regulation: NOM 220-SSA1-2016
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.