Anvisa to hold public hearing on regulatory framework for herbal medicines
Event will address rules that directly impact the herbal medicine sector and cannabis-based products; participation is open to the public.
Anvisa will hold a public hearing on February 6, 2025, to discuss the revision of the regulatory framework for industrialized herbal medicines. The event will take place from 8:30 am to 12 pm at Anvisa's headquarters auditorium in Brasília, Brazil, and is open to all interested parties, including companies and citizens, without the need for prior registration, respecting the space's capacity limit.
Relation to RDC 327/2019
Cannabis-based products, such as extracts, are directly related to herbal medicine regulations. When a company applies for the registration of a cannabis product as a medicine, it must meet all the quality requirements established in these regulations. Therefore, the public hearing is an opportunity to clarify doubts about the proposed normative text in public consultation and assess the impact of the suggested changes.
Regulatory Impact Analysis
The regulatory review includes Regulatory Impact Analysis (RIA), which evaluates the possible effects of the proposed changes. This process usually occurs after the publication of the RIA report and the public consultation, as in the case of herbal medicines. The public hearing is essential for collecting contributions and aligning expectations between regulators and the interested public.
Topics under discussion
Among the documents to be discussed, the following stand out:
- CP n. 1290/2024: Proposes new rules for the registration and notification of herbal medicines and traditional products.
- CP n. 1291/2024: Defines prohibitions and restrictions applicable to the composition of herbal medicines.
- CP n. 1292/2024: Lists permitted pesticides in the analysis of herbal medicines.
- CP n. 1293/2024: Revision of the lists for simplified registration of medicines and herbal products.
The technical documents and guides are available on the Anvisa portal for consultation and contribution until March 2025.
Open and inclusive participation
The public hearing represents an opportunity for companies, healthcare professionals, and the general public to clarify doubts and contribute to the improvement of the regulatory framework. The proposed changes aim to ensure greater safety and quality in the products available on the market, with a direct impact on sectors such as herbal medicines and medical cannabis.
Service
Public Hearing on Herbal Medicines
- Date: February 6, 2025
- Time: 8:30 am to 12 pm
- Location: Anvisa Auditorium, Brasília, Brazil
- Registration: Not required; access on a first-come, first-served basis.
More information and documents are available at:
Public consultations on herbal medicines