Mexico’s medicines regulator, Cofepris, is now recognizing good manufacturing practice certificates for manufacturers producing biologic medicines in other countries, including new innovative products and biosimilars.
Mexico To Expand Recognition Of International GMP Certificates For Biologic Medicines
Moves to widen GMP certificate recognition are in line with World Health Organization recommendations on Good Reliance Practices and with the Mexican government’s strategy for regulatory certainty for the pharmaceutical sector, says the country’s drugs regulator.

More from Latin America
Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
More from Geography
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.