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.
Food Supplements in Latin America : Market overview and Regulations
Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region.This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
Registration of Biologics in Mexico : Frequently asked Questions
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.
Registration of Biologics in Brazil
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.
Mexico’s Cofepris releases provision for ventilator requirements during COVID-19 Pandemic.
On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic.
Registration of a New Molecule in Mexico
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS