§ 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
Authority & dossier
Regulatory authority	ANVISA	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
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)
Pathway name	Standard Drug Registration (Registro de Medicamento)	New Drug Application — 505(b)(1)
Approval timeline	365–730 days	304–365 days
Application fee	BRL 195,000	USD 4,310,002
Annual renewal	BRL 0	USD 416,734
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	No
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.	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.
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	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +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.
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.
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.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Not permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	90–180 days	30–30 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
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)	ICER (Institute for Clinical and Economic Review) — independent, non-binding

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

Authority & dossier

Regulatory authority

BrazilANVISA
United StatesFDA

English submissions

BrazilNo
United StatesYes

CTD accepted

BrazilYes
United StatesYes

eCTD accepted

BrazilYes
United StatesYes

Reliance pathway

BrazilAvailable
United StatesNone

Reference agencies

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

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

Pathway name

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

Approval timeline

Brazil365–730 days
United States304–365 days

Application fee

BrazilBRL 195,000
United StatesUSD 4,310,002

Annual renewal

BrazilBRL 0
United StatesUSD 416,734

Local representative

BrazilRequired
United StatesNot required

Local manufacturing

BrazilNot required
United StatesNot required

GMP inspection

BrazilRequired
United StatesRequired

MAH & local presence

Local entity required

BrazilYes
United StatesNo

Local responsible person

BrazilYes
United StatesYes

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.

Accelerated pathways

Designations available

Brazil4 designations
United States6 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

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.

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.

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.

Unlicensed access

Named Patient Supply

BrazilAvailable
United StatesAvailable

Compassionate Use

BrazilAvailable
United StatesAvailable

Emergency Import

BrazilAvailable
United StatesAvailable

Parallel Import

BrazilNot permitted
United StatesNot permitted

Clinical trials

CTA approval

BrazilRequired
United StatesRequired

Ethics approval

BrazilYes
United StatesYes

CTA timeline

Brazil90–180 days
United States30–30 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

Pricing & reimbursement

Price regulation

BrazilRegulated
United StatesFree pricing

Reference pricing

BrazilYes
United StatesNo

HTA required

BrazilYes
United StatesNo

HTA body

BrazilCONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding