§ 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	🇦🇷Argentina	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	ANMAT	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Swissmedic +6	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Registro de Especialidad Medicinal — Vía Nacional (Standard) · International Recognition Procedure (IRP)
Pathway name	Registro de Especialidad Medicinal — Vía Nacional (Standard)	International Recognition Procedure (IRP)
Approval timeline	270–540 days	60–110 days
Application fee	ARS 5,000,000	GBP 35,305
Annual renewal	ARS 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	A Director Técnico (a registered pharmacist or qualified profesional) must be designated under Decree 1490/92 and ANMAT regulations and is personally accountable for compliance. Pharmacovigilance is led by a designated Responsable de Farmacovigilancia under Disposición 5358/2012.	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	2 designations	4 designations
Examples	Trámite Prioritario / Vacuna en Emergencia, Programa de Acceso Expandido (PAE)	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Post-approval changes (modificaciones al registro) classified by ANMAT into administrative, technical (minor and major) and notifications. Major technical changes (manufacturing site, formulation, indication) require ANMAT approval; minor changes follow notification timelines under INAME guidance.	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	Registration certificate (Certificado de Inscripción en el REM) valid for 5 years; renewal application (reválida) must be filed before expiry per Decree 150/92, with updated safety information and renewal fee.	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	Pharmacovigilance regulated by Disposición 5358/2012 (Good Pharmacovigilance Practices). MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted), submit PSUR/PBRER per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics. Argentina is a WHO-UMC member contributing to VigiBase.	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	70–120 days	30–60 days
GCP standard	ANMAT Disposición 6677/2010 — Régimen de Buena Práctica Clínica para Estudios de Farmacología Clínica (aligned with ICH-GCP E6)	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Free pricing	Regulated
Reference pricing	Yes	No
HTA required	No	Yes
HTA body	Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC)	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

ArgentinaANMAT
United KingdomMHRA

English submissions

ArgentinaNo
United KingdomYes

CTD accepted

ArgentinaYes
United KingdomYes

eCTD accepted

ArgentinaNo
United KingdomYes

Reliance pathway

ArgentinaAvailable
United KingdomAvailable

Reference agencies

ArgentinaFDA, EMA, MHRA, Swissmedic +6
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Registro de Especialidad Medicinal — Vía Nacional (Standard) · International Recognition Procedure (IRP)

Pathway name

ArgentinaRegistro de Especialidad Medicinal — Vía Nacional (Standard)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Argentina270–540 days
United Kingdom60–110 days

Application fee

ArgentinaARS 5,000,000
United KingdomGBP 35,305

Annual renewal

ArgentinaARS 0
United KingdomGBP 0

Local representative

ArgentinaRequired
United KingdomNot required

Local manufacturing

ArgentinaNot required
United KingdomNot required

GMP inspection

ArgentinaRequired
United KingdomNot required

MAH & local presence

Local entity required

ArgentinaYes
United KingdomYes

Local responsible person

ArgentinaYes
United KingdomYes

RP role

ArgentinaA Director Técnico (a registered pharmacist or qualified profesional) must be designated under Decree 1490/92 and ANMAT regulations and is personally accountable for compliance. Pharmacovigilance is led by a designated Responsable de Farmacovigilancia under Disposición 5358/2012.
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

Argentina2 designations
United Kingdom4 designations

Examples

ArgentinaTrámite Prioritario / Vacuna en Emergencia, Programa de Acceso Expandido (PAE)
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

ArgentinaPost-approval changes (modificaciones al registro) classified by ANMAT into administrative, technical (minor and major) and notifications. Major technical changes (manufacturing site, formulation, indication) require ANMAT approval; minor changes follow notification timelines under INAME guidance.
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

ArgentinaRegistration certificate (Certificado de Inscripción en el REM) valid for 5 years; renewal application (reválida) must be filed before expiry per Decree 150/92, with updated safety information and renewal fee.
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

ArgentinaPharmacovigilance regulated by Disposición 5358/2012 (Good Pharmacovigilance Practices). MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted), submit PSUR/PBRER per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics. Argentina is a WHO-UMC member contributing to VigiBase.
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

ArgentinaAvailable
United KingdomAvailable

Compassionate Use

ArgentinaAvailable
United KingdomAvailable

Emergency Import

ArgentinaAvailable
United KingdomAvailable

Parallel Import

ArgentinaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

ArgentinaRequired
United KingdomRequired

Ethics approval

ArgentinaYes
United KingdomYes

CTA timeline

Argentina70–120 days
United Kingdom30–60 days

GCP standard

ArgentinaANMAT Disposición 6677/2010 — Régimen de Buena Práctica Clínica para Estudios de Farmacología Clínica (aligned with ICH-GCP E6)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

ArgentinaFree pricing
United KingdomRegulated

Reference pricing

ArgentinaYes
United KingdomNo

HTA required

ArgentinaNo
United KingdomYes

HTA body

ArgentinaComisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)