Overview
The year 2025 has proved decisive for the evolution of the health regulatory framework in Brazil. With a focus on greater safety, traceability and modernization of systems, Anvisa has published new standards, technical updates and strategic guidelines that directly impact sectors such as biological products, cosmetics and health products.
Introduction
In 2025, Anvisa intensified the improvement of the regulatory framework for three major categories of products – biologicals, cosmetics and medical devices. The changes offer significant opportunities for consulting companies specializing in health registration.
1. Biological products - more clarity and agility
Anvisa has published Technical Note 51/2025, improving the flow of registration and post-registration of biological products.
- Better definition of minimum content in petitions.
- Requirements in line with clinical evidence and global standards.
- Estimated gains in productivity and reduction of rework during the evaluation process
2. Cosmetics - framework for Cosmetovigilance
- Anvisa published Collegiate Board Resolution (RDC) 894, of August 27, 2024, which establishes the guidelines for Good Cosmetic Surveillance Practices for cosmetic product companies.
3. Handmade cosmetics - Easy for small producers
- A bill approved in the Senate (PL 1.281/2022) provides for simplified rules for handmade cosmetics, with exemption from registration with Anvisa as long as they meet the health conditions. This could generate demand for consultancy in adapting small manufacturers to the new requirements, promoting compliance even with light processes.
Why now is the ideal time for regulatory consultancies?
Benefits | What changes | Consulting opportunity |
| Higher standards | New requirements for biologicals and cosmetics | Review of dossiers, risk management plans, technical suitability |
| New systems | Migration to “Solicita/Datavisa” | Monitoring electronic processes, training, audits |
| Supporting small | simplified legal framework | Preparation of guidelines, help with formalities |
Conclusion
Anvisa’s current regulatory movement – with a focus on cosmetovigilance, electronic platforms and clarity on biologics – reinforces the demand for specialized regulatory consultancy. Helping clients adapt, avoid risks and speed up approvals is a competitive differentiator.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.