On March 20, the Brazilian Health Regulatory Agency (Anvisa) published an update to the List of Reference Medicines (LMR), a key regulatory milestone for the pharmaceutical industry in Brazil. The LMR establishes which innovative drugs serve as the basis for generics and similar medications, ensuring standards of safety, efficacy, and quality.

This update does not affect already registered medicines but may have a direct impact on ongoing projects and new regulatory submissions. The main areas affected include:

• Ongoing Development Projects – Companies must review whether the reference medicines they are using remain on the LMR or have been replaced. These changes can influence technical requirements and regulatory timelines.
• Generic and Similar Drug Registration – If a reference medicine has been modified, manufacturers must ensure their products comply with Anvisa’s updated regulations.
• Continuous Monitoring – The update may create opportunities for new product launches or require strategic adjustments in existing projects.

Key Actions for Companies

Given these changes, it is crucial for companies to carefully analyze the new LMR to prevent regulatory and operational impacts on ongoing projects. Recommended actions include:

• Verify whether the reference medicine used in your projects is still on the list.
• If a substitution occurred, assess its impact on regulatory and technical processes.
• Consult with specialists to align with Anvisa’s updated guidelines.

If you need further insights into how this update may affect your projects and want to ensure compliance with regulatory requirements, our team is available to assist you.