Event will address standards that directly impact the herbal medicine and cannabis-based products sector; participation is open to the public.
On February 6, 2025, Anvisa will hold a public hearing to discuss the review of the regulatory framework for industrialized herbal medicines. The event will take place from 8:30 am to 12:00 pm, in the auditorium of Anvisa´s headquarters in Brasília (DF), and is open to all interested parties, including companies and citizens, without the need for prior registration, respecting the space´s capacity limit.
Relationship with RDC 327/2019
Cannabis-based products, such as extracts, are directly related to the herbal medicine standards. When a company requests the registration of a cannabis product as a medicine, it must meet all the quality requirements established in these standards. Thus, the public hearing is an opportunity to clarify doubts about the proposed regulatory text under public consultation and evaluate the impact of the suggested changes.
Regulatory Impact Analysis
The regulatory review includes the Regulatory Impact Analysis (RIA), which assesses 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 to gather contributions and align expectations between regulators and the interested public.
Topics under discussion
Among the documents that will be discussed, the following stand out:
CP No. 1290/2024: Proposes new rules for the registration and notification of herbal medicines and traditional products.
CP No. 1291/2024: Defines prohibitions and restrictions applicable to the composition of herbal medicines.
CP No. 1292/2024: Lists pesticides permitted in the analysis of herbal medicines.
CP No. 1293/2024: Review of the simplified registration lists of herbal medicines and products.
The technical documents and guides are available on the Anvisa portal for consultation and contributions until March 2025.
Open and inclusive participation
The public hearing represents an opportunity for companies, health 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 medicinal cannabis.
Service
Public Hearing on Herbal Medicines
Date: February 6, 2025
Time: 8:30 a.m. to 12:00 p.m.
Location: Anvisa Auditorium, Brasília (DF)
Registration: Not required; access on a first-come, first-served basis.
Source: https://sechat.com.br/noticia/anvisa-realizara-audiencia-publica-sobre-marco-regulatorio-de-fitoterapicos
Anvisa to hold public hearing on regulatory framework for herbal medicines
