Regulatory Agenda of Anvisa for the Biennium 2024-2025
In mid-2023, the National Health Surveillance Agency (Anvisa) initiated the process of constructing its Regulatory Agenda for the Biennium 2024-2025. This planning instrument aims to guide the Agency´s actions by establishing priority issues to be addressed during a specific period. The purpose of this document is to provide predictability and transparency to Anvisa´s regulatory normative activity.
To enable citizens to provide input on the 102 proposals that would comprise the Regulatory Agenda for this and the next year, the development was initiated through a consultation directed at both the public and entities within the National Health Surveillance System (SNVS) regarding the topics to be addressed.
After 45 days of consultation, 1,449 contributions were registered from various stakeholders, with 60% coming from representatives or professionals in the regulated sector and 17% from consumers or representative entities. The macro-theme with the highest number of contributions was Food, totaling 480, followed by Pharmaceuticals with 320, Cross-cutting Issues with 202, Health Services with 86, and Health Products with 68.
To analyze the received contributions, the Regulatory Quality Improvement Advisory of Anvisa (Asreg) developed a tool that utilizes artificial intelligence to group them by similar content, thereby optimizing the evaluation process.
After the analysis, prioritization, and selection of regulatory topics by the technical areas and directorates of the Agency, 91 topics were included, and 21 were excluded, resulting in a final list of 172 themes.
Approved Agenda
On December 15, 2023 the Collegiate Directorate of Anvisa (Dicol) approved the Regulatory Agenda containing 172 regulatory topics distributed across 16 macro-themes: Agrochemicals; Food; Cross-cutting Issues; Cosmetics; Pharmacopoeia; Pharmaceutical Inputs; Analytical Laboratory; Pharmaceuticals; Organization and Management of the National Health Surveillance System (SNVS); Ports, Airports, and Borders; Health Products; Sanitation; Blood, Tissues, Cells, and Organs; Services of Interest to Health; Health Service; and Tobacco.
Among the macro-themes with the highest number of regulatory topics, Pharmaceuticals stand out with 45 themes, Food with 34 and Cross-cutting Issues with 23. According to the Agency, out of the 172 items on the new Agenda, 106 of them (62%) are related to processes from the 2021-2023 Agenda. The remaining 66 represent new regulatory topics.
Futhermore, according to Anvisa all of them are aligned with the objectives of the Estrategic plan 2024-2027 and demonstrate feasibility for progress during the term of the new Agenda.
Highlights from the Pharmaceuticals Macro-theme:
• Update of technical and regulatory requirements for the registration of biological products.
• International alignment of parameters for the validation of analytical methods for drugs (revision of RDC 166/2017);
• Consolidation of post-registration norms for drugs (revision of RDC 73/16, RDC 708/22 and RDC 413/20);
• Formalization of the National Pharmacovigilance System;
• Procedures for discontinuation and reactivation of manufacturing and importation of drugs;
• Registration and post-registration of specific drugs (revision of 24/2011 and RDC 76/2016);
• Regulation of innovation in the areas of drugs and biological products;
• Revision of the regulatory framework regarding post-registration changes in biological products and their cancellation,
• Requirements for proving the safety and efficacy of post-registration petitions (revision of RDC 73/2016);
• Minimum requirements for the validation of bioanalytical methods used in registration and post-registration studies of drugs (revision of RDC 27/2012);
• Requirements for a simplified procedure for registration, post-registration, and renewal of drug registration requests;
• Revision of the regulation of cannabis for medical purposes (revision of RDC 327/2019)
• Revision of the regulation for conducting clinical trials with drugs in Brazil (revision of RDC 9/2015);
• Revision of the regulation for expanded access programs, compassionate use, and post study drug supply (revision of RDC 38/2013);
• Revision of criteria for categorizing registration, post-registration, and prior approval petitions in clinical drug research as a public relevance (revision of RDC 204/2017 and RDC 205/2017);
• Revision of quality requirements for the preparation of registration and post-registration dossiers for synthetic drugs (revision of RDC 73/2016 and the quality section of RDC 753/2022);
• Commitment letter for registration, post-registration, or temporary authorization for emergency use of drugs.
To view the complete agenda, visit: Agenda regulatória — Agência Nacional de Vigilância Sanitária - Anvisa (www.gov.br)
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