Overview
On March, 2026, ANVISA published Normative Instruction (IN) No. 428, bringing crucial updates to the Reference Medicines List (LMR). This movement is vital for companies seeking to register generics and similar drugs, ensuring that bioequivalence and bioavailability studies use the correct comparator.
Introduction
In the dynamic Brazilian pharmaceutical market, the registration of generic and similar medicines depends directly on a safety and efficacy benchmark: the Reference Medicine. Without an updated list, innovation stagnates, and the population’s access to more affordable treatments is hindered.
The recent publication of Normative Instruction No. 428/2026 by ANVISA is not merely an administrative routine; it is a strategic step toward increasing competitiveness and transparency in the sector. It allows new molecules and combinations to enter the radar of both national and international pharmaceutical companies.
What is the LMR and why is the March 2026 update vital
The LMR is the official document indicating which products hold the proof of efficacy, safety, and quality to serve as the standard. IN No. 428/2026 revises these indications, including new drugs that have lost patent exclusivity or whose registration holders requested inclusion as a reference.
Structural Changes and New Inclusions
The update on March 6 brought three main points of attention for Regulatory Affairs departments:
- Inclusion of New Ingredients: Active Pharmaceutical Ingredients (APIs) that previously lacked a defined reference now have an official comparator.
- Strategic Substitutions: Cases where the previous reference medicine was discontinued or had its registration canceled, being replaced by a new one elected by the agency
- Harmonization of Concentrations: Adjustments in specific dosages to align the Brazilian market with current therapeutic needs.
The Impact on Competitiveness and Bioequivalence Studies
For a generic to be approved, it must prove to be identical to the reference in terms of bioavailability. With the new list:
- Reduction of Uncertainties: Companies gain legal and technical predictability before starting their laboratory tests.
- Accelerated Registrations: A clear definition of the comparator reduces the number of ” get in touch ” (formal requests for information) during the dossier analysis by ANVISA.
- Price and Access: Greater regulatory clarity attracts more manufacturers, increasing supply and reducing the final cost of medicines.
Conclusion
The Normative Instruction No. 428/2026 reinforces ANVISA’s commitment to procedural speed without compromising sanitary safety. For managers and responsible pharmacists, constant monitoring of this list is mandatory to avoid investing in studies using obsolete comparators.
At GRP Brazil, we assist our partners in the technical interpretation of these changes, ensuring that the path from development to the pharmacy shelf is as efficient as possible.
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
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References
Learn more about Anvisa.
- National Health Surveillance Agency (ANVISA). Normative Instruction No. 428, March 6, 2026. Updates the Reference Medicines List. Official Gazette of the Union, Brasília, DF.
- ANVISA Collegiate Board Resolution – RDC No. 657/2024. Provides for the criteria for indication, inclusion, and exclusion of medicines in the LMR.
- Impact Report of New Regulations on the Generics Market 2026.
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.