§ 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 Kingdom
Authority & dossier
Regulatory authority	ANVISA	MHRA
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	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Drug Registration (Registro de Medicamento) · International Recognition Procedure (IRP)
Pathway name	Standard Drug Registration (Registro de Medicamento)	International Recognition Procedure (IRP)
Approval timeline	365–730 days	60–110 days
Application fee	BRL 195,000	GBP 35,305
Annual renewal	BRL 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not 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 (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Priority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
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	30–60 days
GCP standard	ICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

BrazilANVISA
United KingdomMHRA

English submissions

BrazilNo
United KingdomYes

CTD accepted

BrazilYes
United KingdomYes

eCTD accepted

BrazilYes
United KingdomYes

Reliance pathway

BrazilAvailable
United KingdomAvailable

Reference agencies

BrazilFDA, EMA (centralised), MHRA, Health Canada +2
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Standard Drug Registration (Registro de Medicamento) · International Recognition Procedure (IRP)

Pathway name

BrazilStandard Drug Registration (Registro de Medicamento)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Brazil365–730 days
United Kingdom60–110 days

Application fee

BrazilBRL 195,000
United KingdomGBP 35,305

Annual renewal

BrazilBRL 0
United KingdomGBP 0

Local representative

BrazilRequired
United KingdomNot required

Local manufacturing

BrazilNot required
United KingdomNot required

GMP inspection

BrazilRequired
United KingdomNot required

MAH & local presence

Local entity required

BrazilYes
United KingdomYes

Local responsible person

BrazilYes
United KingdomYes

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 KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Brazil4 designations
United Kingdom4 designations

Examples

BrazilPriority Procedure (RDC 204/2017), Optimised Analysis Reliance (RDC 205/2017), Orphan Drug Designation (Medicamento Órfão) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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 KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

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 KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

BrazilAvailable
United KingdomAvailable

Compassionate Use

BrazilAvailable
United KingdomAvailable

Emergency Import

BrazilAvailable
United KingdomAvailable

Parallel Import

BrazilNot permitted
United KingdomPermitted

Clinical trials

CTA approval

BrazilRequired
United KingdomRequired

Ethics approval

BrazilYes
United KingdomYes

CTA timeline

Brazil90–180 days
United Kingdom30–60 days

GCP standard

BrazilICH-GCP E6(R3); Brazilian GCP under RDC 9/2015 + Law 14.874/2024
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

BrazilRegulated
United KingdomRegulated

Reference pricing

BrazilYes
United KingdomNo

HTA required

BrazilYes
United KingdomYes

HTA body

BrazilCONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)