The Collegiate Board of the Brazilian Health Regulatory Agency (Anvisa) approved the Regulatory Agenda (RA) for the 2024-2025 cycle on December 15, 2023, effective as of January 2, 2024, outlining key topics to be discussed and regulated by the agency.
Process
The document will be part of the Annual Agencies Plan, as per Law No. 13,848/2019 (Regulatory Agencies Law), serving as a planning, management, and transparency tool for Anvisa’s regulatory activities.
Preparation of the 2024-2025 RA involved the input from society and entities of the National Health Surveillance System (SNVS). A total of 1,449 contributions were received by Anvisa during a public consultation.
Key Points and Common Themes
The 2024-2025 RA encompasses 172 regulatory topics grouped into 16 macro-themes, with 106 related to the 2021-2023 Agenda and 66 new themes.
Highlights
Cross-Cutting Issues
- Authorization for depleting stock of products under health surveillance.
- Regulation of the issuance, prescription, dispensing, and storage of Special Control and electronic prescriptions for antimicrobial medications.
- Requirements for accepting analyses by Equivalent Foreign Regulatory Authorities in Inspection and Good Practices Certification processes.
- Requirements for the regularization of human-use antiseptic products.
- Requirements for the regularization of products for aesthetic procedures with dermal action.
Pesticides
- Oversight of regulations of pesticide advertising.
Food
- Good Practices for Food Services.
- Identification of strategies to provide necessary information for safe food consumption by visually impaired individuals.
- Regulation of the recycling of plastic materials in contact with food.
- Regulation of plant-based foods.
- Revision of nutritional and general labeling regulations for packaged foods.
- Revision of Good Manufacturing Practices (GMP) standards for food processing establishments.
Cosmetics
- Revision of Cosmetics surveillance norms.
- Update of lists of permitted (preservatives, dyes, filters, and straighteners), restricted, or prohibited substances in personal hygiene, cosmetic, and perfume products.
Medicines and Pharmaceutical Inputs
- Good Practices requirements for the fractioning and distribution of pharmaceutical inputs.
- Update of technical and regulatory requirements for the registration of Biological Products.
- Consolidation of post-registration norms for medicines.
- Procedures for discontinuation of manufacturing or importation of medicines, as well as reactivation.
- Revision of pharmacovigilance good practices for medicine registration holders.
- Revision of regulations for Cannabis products for medicinal purposes.
- Revision of regulations for conducting clinical trials with medicines in Brazil.
Products and Health Services
- Revision of Good Practices in pharmacies and drugstores, including the preparation of a draft to amend the Collegiate Board Resolution No. 44/2009 in the aspects related to health services in pharmacies.
- Instructions for use in electronic format for user-friendly medical devices.
- Regulation of innovation in medical devices.
- Revision of the regulatory framework for Software as a Medical Device (SaMD).
- Revision of techno vigilance regulatory framework focusing on companies holding health product registrations.
- Healthcare Facility Infrastructure.
Additionally, there are themes that may impact analytical laboratories, ports, airports, borders, sanitizers, and tobacco industries.
For more information
To access the full Regulatory Agenda, click here.
Our Life Sciences team is available to assist you with this matter and to provide any necessary clarifications to your company.
