A legal modification has recently been achieved for the faster recognition and release of innovative medicines on the Mexican market.
On 24 August 2023, the Federal Commission for the Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) announced important measures as part of the Regulatory Certainty Strategy for the Pharmaceutical Sector. These measures aim to harmonize the legal framework to enhance access to high-quality biotechnological and biosimilar medicines for the population.
Biotechnological medicines are innovative pharmaceutical products, made from living organisms that offer more effective and less toxic treatments for a wide range of diseases. These medications are used to treat autoimmune diseases, certain types of cancer, rare diseases, and genetic disorders, among others. Its importance will continue to grow as we move towards an era of personalized medicine.
In Mexico and other Latin American countries, both innovative biological medicines and authorized biocomparable medicines are marketed and distributed with the same international non-proprietary name of the active substance [1].
Currently, the majority of biotechnological and biosimilar drugs consumed in Mexico are manufactured abroad, so effective regulatory coordination is required for these high-quality medicines to be available on the national market.
Up until now, the Official Mexican Standard NOM-059-SSA1-2015 has mandated that companies manufacturing these medicines outside the country obtain a Certificate of Good Manufacturing Practices (GMP) from COFEPRIS to release them within the national territory. This obligation existed even when COFEPRIS already recognized the GMP issued by other health authorities accredited by the World Health Organization (WHO) and/or the Pan American Health Organization (PAHO) or members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Recognizing the challenge, COFEPRIS has initiated the Emergency Modification to NOM-059-SSA1-2015 published in the Official Gazette of the Federation (DOF) in order to improve access to these vital medications.
The release of imported biotechnological products will be carried out with analyses prepared by the manufacturer's quality control laboratory and COFEPRIS will monitor the correct execution of the release process through the Post-Marketing Surveillance Program (PVP).
With this action, COFEPRIS advances in the harmonization of the legal framework with the highest international standards through actions aligned with the WHO recommendations on Reliance Good Practices (GRelP) and strengthens confidence in the decisions of other health authorities.
It is important to consider that, along with this action, the Regulatory Certainty Strategy for the Pharmaceutical Sector provides for complementary actions to promote the manufacturing of biotechnological and biosimilar medicines in Mexico, with the purpose of contributing to the health self-sufficiency of our country and the Latin America and the Caribbean region.
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LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View the latest headline article: Avances en la disponibilidad de medicamentos innovadores en México Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Ver el último artículo de cabecera: Avances en la disponibilidad de medicamentos innovadores en México !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Nomenclature of biologicals and biocomparables in Mexico[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 31]. Available from: www.gabionline.net/policies-legislation/nomenclature-of-biologicals-and-biocomparables-in-mexico
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