§ 02 · Comparison
Compare regulatory pathways side-by-side
Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.
Lead pathway (timeline & fees), Standard Drug Registration (Registro de Medicamento) · Centralised Procedure
Pathway name
- BrazilStandard Drug Registration (Registro de Medicamento)
- European UnionCentralised Procedure
Approval timeline
- Brazil365-730 days
- European Union210-277 days
Headline fee and pathway
- BrazilBRL 80,000, Standard Drug Registration (Registro de Medicamento)conditional on company size
- European UnionEUR 865,200, Centralised Procedureconditional on other
Recurring charges
- BrazilRenewal applies, amount not published, every 10 years, per registration
- European UnionEUR 232,400 a year, per marketing authorisation, other applications
Local representative
- BrazilRequired
- European UnionRequired
Local manufacturing
- BrazilNot required
- European UnionNot required
GMP inspection
- BrazilRequired
- European UnionRequired
MAH & local presence
Local entity required
- BrazilYes
- European UnionYes
Local responsible person
- BrazilYes
- European UnionYes
RP role
- BrazilResponsável Técnico (RT): Brazilian-resident pharmacist registered with the regional Pharmacy Council (CRF) responsible for technical oversight. A separate Pharmacovigilance Officer is required under RDC 406/2020.
- European UnionQualified Person Responsible for Pharmacovigilance (QPPV), must reside and operate in the EU/EEA, is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
Accelerated pathways
Designations available
- Brazil4 designations
- European Union6 designations
Examples
- BrazilPriority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1
- European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework
- BrazilPost-approval changes classified under RDC 73/2016 (synthetics) and RDC 49/2011 (biologics) using a tiered system: implementation pre-approval (categoria 1) for major changes, immediate implementation with notification (categoria 2) for minor changes, and annual reporting (categoria 3) for the smallest changes. Largely aligned with EU/ICH classification.
- European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor, Do and Tell, 12-month notification), Type IAIN (minor, immediate notification), Type IB (minor, Tell, Wait, and Do, 30-day default), Type II (major, prior approval, 60 to 90 days), and Extensions (Annex I changes, full review). Worksharing procedures consolidate variations across multiple authorisations.
Renewal cycle
- BrazilMarketing authorisations valid for 10 years; renewal application due 12 months before expiry. Renewal requires updated safety/efficacy data and pharmacovigilance summary. Failure to renew results in cancellation.
- European UnionInitial 5-year renewal, application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
Pharmacovigilance
- BrazilBrazilian Good Pharmacovigilance Practices under RDC 406/2020. Mandatory pharmacovigilance system with designated Pharmacovigilance Officer. PSURs aligned with ICH E2C(R2). Vigimed electronic reporting system for ADRs.
- European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
Unlicensed access
Named Patient Supply
- BrazilAvailable
- European UnionAvailable
Compassionate Use
- BrazilAvailable
- European UnionAvailable
Emergency Import
- BrazilAvailable
- European UnionAvailable
Parallel Import
- BrazilNot permitted
- European UnionPermitted
Clinical trials
CTA approval
- BrazilRequired
- European UnionRequired
Ethics approval
- BrazilYes
- European UnionYes
CTA timeline
- Brazil90-180 days
- European Union60-106 days
GCP standard
- BrazilICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024
- European UnionICH E6(R3), Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation
- BrazilRegulated
- European UnionRegulated
Reference pricing
- BrazilYes
- European UnionYes
HTA required
- BrazilYes
- European UnionYes
HTA body
- BrazilCONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)
- European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)