§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇧🇷Brazil	🇪🇺European Union
Authority & dossier
Regulatory authority	ANVISA	EMA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +2	—
Lead pathway (timeline & fees) — Standard Drug Registration (Registro de Medicamento) · Centralised Procedure
Pathway name	Standard Drug Registration (Registro de Medicamento)	Centralised Procedure
Approval timeline	365–730 days	210–277 days
Application fee	BRL 195,000	EUR 358,800
Annual renewal	BRL 0	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	Responsável 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.	Qualified 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	4 designations	6 designations
Examples	Priority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
Post-approval lifecycle
Variations framework	Post-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.	Commission 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, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate variations across multiple authorisations.
Renewal cycle	Marketing 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.	Initial 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	Brazilian 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.	Comprehensive 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	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	90–180 days	60–106 days
GCP standard	ICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

BrazilANVISA
European UnionEMA

English submissions

BrazilNo
European UnionYes

CTD accepted

BrazilYes
European UnionYes

eCTD accepted

BrazilYes
European UnionYes

Reliance pathway

BrazilAvailable
European UnionAvailable

Reference agencies

BrazilFDA, EMA (centralised), MHRA, Health Canada +2
European Union—

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

Application fee

BrazilBRL 195,000
European UnionEUR 358,800

Annual renewal

BrazilBRL 0
European UnionEUR 122,500

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, 60–90 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.)