Regulatory Certainty Strategy for biosimilars launched in Mexico

In February 2024, Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.

The proposed RCS strategic plan, https://www.gob.mx/cms/uploads/attachment/file/792036/Estrategia_de_Certidumbre_Regulatoria_para_el_sector_Farmaceutico_enero_2023.pdf, aims to provide regulatory certainty to companies in the pharmaceutical sector in order to bring medical innovation and productive development to the market.

Mr Alejandro Svarch Pérez, Head of COFEPRIS, launched the ‘Regulatory Certainty Strategy for the Pharmaceutical Sector: Biosimilars’ on 9 February 2024, with the aim to establish a robust regulatory and operational framework to support and promote the production and development of biosimilar biotechnological drugs.

Firstly, it seeks to promote the development of biocomparable biotechnological medicines that are created specifically for Mexico, aiming to achieve technological autonomy in this field. Additionally, it establishes a solid regulatory framework aligned with international standards to provide certainty to local manufacturers and guarantee the quality, safety and efficacy of medicines. Finally, it aims to enhance the capacity of the pharmaceutical industry through regulatory support at all stages of research and production of pharmaceutical products.

Regulatory certainty means a simplification without deregulation, to avoid unnecessary bureaucracy and situations prone to corruption.

COFEPRIS defines regulatory certainty as full compliance with the regulatory framework for protection against health risks. This involves establishing complete transparency between regulators and those being regulated. It's about meeting objectives and commitments that help rebuild a healthcare system under the leadership of the State.

The new RCS for biosimilars will serve as a guide to the institutional and regulatory framework aligned with international standards, providing regulatory certainty to promote the industry's capacity in all phases of research and production of these products.

The proposed RCS strategic plan, to be implemented during the period 2024–2026, will provide guidelines for the institutional and regulatory framework to conform to international standards, fostering the industry's capacity in all phases of research and production of these products.

The actions contemplated in this strategy first seek to promote the development of biocomparable biotechnological medicines, which are created specifically for Mexico, with the aim of achieving technological autonomy in this area. In addition, it is intended to establish a solid regulatory framework aligned with international standards to provide certainty to local manufacturers and guarantee the quality, safety and effectiveness of medicines. Finally, it seeks to boost the capacity of the pharmaceutical industry through regulatory support in all stages of research and production of pharmaceutical products.

COFEPRIS updates its regulatory system regularly. For instance, in May 2021, a new decree, the Reglamento de Insumos para la salud (RIS), significantly modified several aspects of the regulatory approval system for biosimilars in Mexico [1].

Brazil and Mexico, major Latin American nations, are in a competitive race to enhance health regulations, showcasing their dedication to upgrading public health infrastructure and ensuring healthcare product safety. Both nations aim to fortify regulatory frameworks and streamline approval processes to tackle emerging health issues, fostering improved healthcare outcomes. Their health regulatory agencies have unveiled strategic plans for 2024-2027 [2].

Mexico introduces new decree on health regulation

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References
1. GaBI Online - Generics and Biosimilars Initiative. A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 9]. Available from: www.gabionline.net/guidelines/a-new-decree-modifies-several-aspects-of-the-regulatory-approval-system-for-biosimilars-in-mexico
2. GaBI Online - Generics and Biosimilars Initiative. Strategic plans of ANVISA and COFEPRIS to advance health regulation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 9]. Available from:
www.gabionline.net/es/politicas-y-legislacion/strategic-plans-of-anvisa-and-cofepris-to-advance-health-regulation

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