The consultation
Consultation No. 1,248 (Aug 26, 2026): a new Class III/IV framework with new clinical-evidence, risk, and software requirements.
Free field guide · PDF
Brazil ANVISA: Clinical Research2026 Field Guide
The consultation that changes everything, the updated law, and the ethics gate — with the ANVISA practice you need.
- Consultation
- No. 1,248
- Feedback
- 45 days
- GCP
- E6(R3)
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The updated law
Clearer post-trial access, investigational-product import during review, and ICH E6(R3)-aligned GCP.
The ethics gate
The CEP/CONEP gate: origin-country justification and registration-status rules your protocol can't miss.
Sources & scope
- youtube.com (Pure Global), Brazil ANVISA Consultation No. 1,248 (2026).
- medium.com/@zenovel12, CRO Setup & Upgradation in Brazil (2026).
- clinregs.niaid.nih.gov, G-ClinProtocols-FAQs (CEP/CONEP ethics).
This guide is market-access intelligence, not regulatory or legal advice. ANVISA clinical requirements, consultation outcomes, and ethics rules change — professional review is required before business use.
Market Access Strategy Session
Brazil on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your ANVISA route — Consultation 1,248 preparation, clinical-research strategy, and BRH planning.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team