ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.
The Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), through a new strategic plan, has outlined its objectives for the next three years (2024-2027), aiming to gain recognition from the WHO while prioritizing initiatives like adopting IDMP standards and modernizing data platforms.
The formulation of ANVISA Strategic Plan for 2024‒2027 cycle began with the realisation of the situational diagnosis, adopting approaches and data collection tools. After that, a Strategic Map was drawn up. The map was made up of the organisational identity and seven strategic objectives, taking into account present and future challenges.
Based on the strategic objectives, established the strategic focuses and, in turn, defined the key results as parameters for measuring and evaluation of these objectives. Finally, a portfolio of strategic projects was built from the perspective of agile management for results, in line with the guidelines established in the Strategic Map.
For ANVISA the specific goals outlined in the new plan involve supporting the process of bringing biological agents to the commercial market within two years after receiving marketing approval and enhancing the quantity of biosimilar medicines or groundbreaking drugs developed in Brazil by a 20% increment. By May 2023, Brazil had 52 follow-on biological medicines and approximately 30 biological products awaiting analysis or already being analysed by ANVISA [1].
Similarly, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios) has disclosed its agenda for 2024, focusing on enhancing regulatory certainty, promoting digitalization, and improving manufacturing capabilities in line with international standards.
COFEPRIS released a document on 30 January 2024 making also public its priorities and work agenda for 2024. They described efforts to promote regulatory certainty, improve confidence in its processes, and expand digitalization as a strategy to speed approvals.
COFEPRIS announced plans for the launch of its biosimilars unit and pharmaceutical development committee in 2024. These initiatives aim to boost Mexican manufacturing. The agency also pledged to improve rules for conducting clinical research to speed up service times.
Regarding medical devices, COFEPRIS aims to harmonize its good manufacturing practice (GMP) requirements with global standards, integrate into the Medical Device Single Audit Program, and remove trade barriers caused by labelling differences. Additionally, COFEPRIS released new detailed guides for registering devices and medicines in Mexico in December 2024.
On 31 May 2021, COFEPRIS introduced a new decree which specified changes to the Health Supplies Regulation (Reglamento de Insumos para la Salud, RIS) [2].
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References
1. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
2. GaBI Online - Generics and Biosimilars Initiative. Mexico introduces new decree on health regulation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 11]. Available from:
www.gabionline.net/guidelines/mexico-introduces-new-decree-on-health-regulation
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