Vita attended the workshop “The Journey of Advanced Therapies in Brazil – Advances, Challenges, and Regulatory Perspectives”, organized by Sindusfarma in partnership with the Brazilian Regulatory Agency (ANVISA).

The event provided a comprehensive and strategic overview of the regulatory, scientific, and institutional landscape of advanced therapies in the country. The main objective of the meeting was to build a timeline for the development of these therapies and to identify opportunities for improvement throughout the regulatory lifecycle.Advanced Therapy Products (ATPs) are classified as medicinal products, considering their unique characteristics and their interface with blood, tissues, cells, organs, and healthcare services. The Brazilian regulatory model addresses the product in an integrated manner with the service in which it is used.

Accordingly, and in alignment with the work carried out by the Office for Blood, Tissues, Cells, Organs, and Advanced Therapy Products (GSTCO), the workshop covered all the necessary stages for these products to reach patients. This includes clinical research, Good Manufacturing Practices, importation, logistics, and treated patients, encompassing all applicable regulatory requirements across these stages. Discussions involved all stakeholders in the value chain, such as the Brazilian Ministry of Health, National Technical Commission on Biosafety (CTNBio), ANVISA, academic and research institutions, and the regulated sector, within the Brazilian context and in comparison with the Latin American region.

It was highlighted that, despite the extensive value chain and its complexity, the regulatory assessment is usually agile, with product approvals occurring in approximately 120 days. In contrast, synthetic medicines may take up to three years to complete the process. This agility is based on specific risk–benefit assessments at each of the aforementioned stages.

Another key point was the ongoing discussion on a new Chamber for the Regulation of the Pharmaceutical Market – CMED (Executive Secretariat of the Chamber for the Regulation of the Pharmaceutical Market – SCMED), legislation inspired by the European model, as well as the draft of the Resolution for the regulation of experimental clinical trials, updates to RDC 506/2021 and post-approval regulatory requirements.

Long-term periodic monitoring, carried out jointly by ANVISA and companies, was defined as a way to “transform initial uncertainties into safety,” based on pillars such as transparency, the publication of periodic reports, and collaborative monitoring.

The course reinforced that Brazil is a highly promising market for advanced therapies, both for new marketing authorizations and for clinical development. ANVISA’s openness to technical dialogue and the joint construction of regulatory solutions is a decisive factor in reducing the time to market for these innovative products, always with a focus on safety, transparency, and patient benefit.