Regulatory updates in 2025 are transforming the landscape for the pharmaceutical, cosmetic, and agrochemical industries in Brazil. Changes in national laws and standards directly affect regulatory compliance, research, and the development of new products, requiring companies to adapt quickly and strategically. Therefore, it is essential for businesses to respond proactively and efficiently to maintain competitiveness and minimize risks.
1. Cosmetics: System Transition and Simplified Registrations
Migration to the “Solicita” Platform
Anvisa has mandated the migration of cosmetic registrations from the old SGAS system to the Solicita/Datavisa platform. This process unification aims to enhance transparency, traceability, and simplify information management. As of April 7, 2025, only requests submitted through the new system will be accepted. Furthermore, companies will have six years to maintain the previous registration number on product labeling. The impact on Research & Development (R&D) is significant: development teams must align technical documentation and safety dossiers to the new format, carefully reviewing all materials in advance to avoid rejections or delays.
Limits on Amendments
Since June 9, 2025, Anvisa only accepts amendments submitted before the start of technical analysis. Therefore, it is increasingly important that the initial dossier is complete, validated, and thoroughly reviewed prior to submission.
Exemption for Artisanal Products
Law 15.154/2025 exempts artisanal products from Anvisa registration, provided they comply with specific rules. This change creates new opportunities for small producers, though attention to future regulations remains crucial to avoid non-compliance.
2. Cosmetics: Post-Market Safety
New Manuals and Guides
Anvisa has published technical materials for inspecting good practices in cosmetovigilance and guidance on RDC 894/2024. Companies must strengthen post-market monitoring to ensure early risk detection and prevent corrective actions such as recalls or restrictions.
Public Consultation on Ingredients
An update to the lists of restricted and prohibited substances is underway. This measure may require product reformulations, affecting both existing products and those under development.
3. Pharmaceutical and Herbal Industries
Revision of RDC 327/2019 (Medical Cannabis)
The proposed revision expands administration routes, authorizes magistral compounding, and encourages national manufacturing. This opens new opportunities for research, development, and innovation projects, especially in emerging therapies.
4. Agrochemicals: New Requirements and Opportunities
National Pesticide Traceability Program (PNRA)
MAPA now requires complete tracking of pesticides, from the manufacturer to reverse logistics. This change impacts the entire supply chain and demands integrated technological traceability systems.
New Registrations Approved
In 2025, MAPA authorized 44 chemical pesticides and 29 bio-inputs. While this expansion offers more development options, it also requires more rigorous regulatory and toxicological assessments.
Innovating with Safety and Proactivity
In a dynamic scenario like 2025, anticipating regulatory requirements is essential to avoid delays and financial losses. Companies leveraging predictive computational analyses, such as those offered by DruGet, can:
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Virtually test safety and efficacy before laboratory studies.
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Adjust formulations according to Anvisa, MAPA, and international regulations.
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Reduce costs and time for submission and approval.
Therefore, integrating science, technology, and compliance has become the safest path to innovate while maintaining competitiveness in the market.
