On August 28, Vita attended the seminar hosted by ANVISA in Brasília on the new regulatory requirements for herbal medicines in Brazil. The event brought together representatives from the Agency, industry, and technical experts to discuss the practical implementation of Resolution RDC 1,004/2025 and its complementary Normative Instructions — published in 2025 as part of the most significant update to Brazil’s herbal medicine regulatory framework in the past decade.

Juliana Amorim, Vita’s herbal medicine specialist, represented the company at the event. Beyond the technical content discussed, the seminar was also a valuable opportunity to connect with partners operating within the same regulatory ecosystem.

For those looking to dive deeper into the technical content of the new regulation, Vita had already published a full analysis of the changes introduced by RDC 1,004/2025 — including the new extract classification, the terminology shift from PTF to MTF, and the updated criteria for safety and efficacy evidence. Read the full article here: 

https://www.vitapharmaconsulting.com/noticias/2026/06/03/anvisa-a-evolucao-do-marco-regulatorio-de-fitoterapicos-no-brasil-uma-analise-tecnica-e-estrategica/

One of the key points discussed at the seminar was the need to expand the portfolio of herbal medicines available in the country. There is documented demand from the public, and ANVISA itself has signaled a willingness to broaden access to these products. However, companies still face challenges in working with herbal medicines. And although the Agency is sparing no effort to publicize and clarify the new regulatory framework, the impact on the sector is significant, and many companies have not yet managed to organize themselves accordingly.

This is where Vita can offer practical support: through training focused on understanding the new regulatory framework, and full technical support for adapting products — whether already registered or in development — to RDC 1,004/2025. There is also a significant opportunity around notified herbal products (produtos notificados), which follow a simplified regulatory pathway — an area where Vita can add direct, practical value to companies in the sector.