Brazil’s Regulatory Transformation For Biologics: What To Expect In 2025

Brazil’s drug regulator ANVISA is changing how biologics and biosimilars get approved. The goal is to make approvals faster, simpler, and more in line with global rules.

Main Changes

1. Online-Only Submissions

• From May 1, 2025, all files must be sent online (no more paper, except CTD).
• What to do: Switch to ANVISA’s online system.

2. Easier Approvals for Some Drugs

• From Jan 21, 2025, some biologics (same company group or tech transfer projects) can use a quicker process.
• What to do: Check if your drug qualifies and send full files by Apr 21, 2025.

3. Faster Approvals Using Foreign Decisions

• ANVISA will accept approvals from agencies like FDA or EMA.
• What to do: Use global approvals to support your Brazil submission.

4. New Path for Biosimilars

• Can use global reference products. Some extra studies may not be needed if strong proof is shown.
• What to do: Prepare strong comparison data.

5. Easier Updates After Approval

• Clearer rules for changes with less paperwork.
• What to do: Update your post-approval process.

6. Stronger Safety Checks

• Safety reports now follow global standards.
• What to do: Update your safety (PV) system.

What’s Coming Next

• New rules for biosimilars with real-world data.
• Simpler, unified rules for all submissions.
• Faster review for clinical trials.
• Full eCTD adoption soon.
• Better systems for ongoing drug monitoring.
• Priority for rare diseases and children’s drugs.
• More support for R&D and new tech.

Benefits

• Faster approvals
• Fully digital system
• Global data accepted
• Less paperwork
• Stronger drug safety

Key Dates

How Maven Can Help

Maven can:

• Plan the right regulatory strategy
• Prepare and submit files in eCTD
• Support post-approval changes
• Guide clinical trials and work with ANVISA

With Maven, you can adapt easily to Brazil’s new rules and get your product to market faster.