§ 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	🇺🇸United States	🇪🇺European Union
Authority & dossier
Regulatory authority	ANVISA	FDA	EMA
English submissions	No	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	Available	None	Available
Reference agencies	FDA, EMA (centralised), MHRA, Health Canada +2	—	—
Lead pathway (timeline & fees) — Standard Drug Registration (Registro de Medicamento) · New Drug Application — 505(b)(1) · Centralised Procedure
Pathway name	Standard Drug Registration (Registro de Medicamento)	New Drug Application — 505(b)(1)	Centralised Procedure
Approval timeline	365–730 days	304–365 days	210–277 days
Application fee	BRL 195,000	USD 4,310,002	EUR 358,800
Annual renewal	BRL 0	USD 416,734	EUR 122,500
Local representative	Required	Not required	Required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Required
MAH & local presence
Local entity required	Yes	No	Yes
Local responsible person	Yes	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.	US Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.	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	6 designations
Examples	Priority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3	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.	FDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.	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.	FDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.	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.	Mandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.	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	Available
Compassionate Use	Available	Available	Available
Emergency Import	Available	Available	Available
Parallel Import	Not permitted	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required	Required
Ethics approval	Yes	Yes	Yes
CTA timeline	90–180 days	30–30 days	60–106 days
GCP standard	ICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Free pricing	Regulated
Reference pricing	Yes	No	Yes
HTA required	Yes	No	Yes
HTA body	CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)	ICER (Institute for Clinical and Economic Review) — independent, non-binding	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
United StatesFDA
European UnionEMA

English submissions

BrazilNo
United StatesYes
European UnionYes

CTD accepted

BrazilYes
United StatesYes
European UnionYes

eCTD accepted

BrazilYes
United StatesYes
European UnionYes

Reliance pathway

BrazilAvailable
United StatesNone
European UnionAvailable

Reference agencies

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

Lead pathway (timeline & fees) — Standard Drug Registration (Registro de Medicamento) · New Drug Application — 505(b)(1) · Centralised Procedure

Pathway name

BrazilStandard Drug Registration (Registro de Medicamento)
United StatesNew Drug Application — 505(b)(1)
European UnionCentralised Procedure

Approval timeline

Brazil365–730 days
United States304–365 days
European Union210–277 days

Application fee

BrazilBRL 195,000
United StatesUSD 4,310,002
European UnionEUR 358,800

Annual renewal

BrazilBRL 0
United StatesUSD 416,734
European UnionEUR 122,500

Local representative

BrazilRequired
United StatesNot required
European UnionRequired

Local manufacturing

BrazilNot required
United StatesNot required
European UnionNot required

GMP inspection

BrazilRequired
United StatesRequired
European UnionRequired

MAH & local presence

Local entity required

BrazilYes
United StatesNo
European UnionYes

Local responsible person

BrazilYes
United StatesYes
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.
United StatesUS Agent: a person residing or maintaining a place of business in the US, designated to act on behalf of the foreign establishment for FDA communications, including notification of inspections.
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
United States6 designations
European Union6 designations

Examples

BrazilPriority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
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.
United StatesFDA classifies post-approval changes as: Annual Reportable, Changes Being Effected (CBE-0 immediate, CBE-30 with 30-day pre-implementation notice), and Prior Approval Supplements (PAS) — the most significant changes requiring FDA approval before implementation. Major manufacturing or labelling changes typically require a PAS.
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.
United StatesFDA does not require periodic renewal of NDAs or BLAs — approvals remain in effect indefinitely subject to compliance, payment of annual program fees, and post-marketing requirements. Annual reports are required.
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.
United StatesMandatory expedited reporting of serious unexpected ADRs within 15 calendar days; periodic safety reports (PADERs/PAERs) for the first 3 years post-approval, then annually. PSURs in ICH E2C(R2) format accepted in lieu of PADERs by agreement. FAERS database receives spontaneous reports. Post-Marketing Requirements (PMRs) and Commitments (PMCs) tracked publicly.
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
United StatesAvailable
European UnionAvailable

Compassionate Use

BrazilAvailable
United StatesAvailable
European UnionAvailable

Emergency Import

BrazilAvailable
United StatesAvailable
European UnionAvailable

Parallel Import

BrazilNot permitted
United StatesNot permitted
European UnionPermitted

Clinical trials

CTA approval

BrazilRequired
United StatesRequired
European UnionRequired

Ethics approval

BrazilYes
United StatesYes
European UnionYes

CTA timeline

Brazil90–180 days
United States30–30 days
European Union60–106 days

GCP standard

BrazilICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

BrazilRegulated
United StatesFree pricing
European UnionRegulated

Reference pricing

BrazilYes
United StatesNo
European UnionYes

HTA required

BrazilYes
United StatesNo
European UnionYes

HTA body

BrazilCONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)