On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Supplies Regulation (Reglamento de Insumos para la Salud, RIS). These changes, most of which are effective immediately, streamline administrative processes, focus on health surveillance, and promote openness and innovation in global health inputs.
The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. The agency is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.
The Health Supplies Regulation (RIS) a legal order that emanates from the General Health Law and aims to regulate the sanitary control of health supplies, establishments, activities and services related to them.
In Mexico, biosimilars are denominated ‘medicamentos biotecnológicos biocomparables’.
The changes introduced to the Health Supplies Regulation include:
- Optimization for extensions of health registration with a focus on quality of supplies. Redundant bureaucratic processes that generated cyclical five-year shortages are no longer needed.
Expansion of capacities for the reception of files in English:
• COFEPRIS eliminates the requirement to submit dossiers only in Spanish, now accepting them also in English, therefore, eliminating the time and cost of expert translations by third parties.
• By accepting submissions in English, Mexico's position as a recipient of global innovation is strengthened, opening the door to new medical developments from around the world.
Longer deadlines are introduced to demonstrate the interchangeability of biotechnological biocomparable medicines in national territory:
• Clinical studies from the country of origin of a new medicine or medical device may be submitted as evidence to initiate consideration for registration.
• Specialized reviewers will review these studies and may recognize them as valid evidence for a first health registration, provided that they comply with quality, safety and efficacy requirements.
• Studies conducted in Mexico will be a requirement for the authorization of extensions of timelines to health registrations, confirming the bioequivalence of the product, which will also be subject to targeted pharmacovigilance.
Differentiated labelling for the public and private sector:
• Harmonizing the amendment to the General Health Law, there will now be differentiated labelling for medicines destined for the public sector. This measure improves transparency, supervision, control and surveillance of medical supplies used by the public health system.
These proposals were previously submitted for public consultation to the National Commission for Regulatory Improvement (Comisión Nacional de Mejora Regulatoria, CONAMER), where they received observations and comments from the public.
With these changes, patient health care is put at the centre of RIS. It also aligns its operations with the highest international standards, contributing to the agency's recertification as a level IV regulatory agency, issued by the Pan American Health Organisation, and soon the World Health Organization's GBT (Global Benchmarking Tool).
Readers interested to learn more about biosimilars in other countries in Latin America are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report
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A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico
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LATIN AMERICAN FORUM
The brand-new section 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 this week’s headline article: México presenta nuevo decreto sobre regulación sanitaria
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LATIN AMERICAN FORUM
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.
Vea el artículo principal de esta semana: México presenta nuevo decreto sobre regulación sanitaria
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