§ 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	🇨🇱Chile	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	ISP / ANAMED	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Swissmedic +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Registro Sanitario — Vía Ordinaria (Standard) · International Recognition Procedure (IRP)
Pathway name	Registro Sanitario — Vía Ordinaria (Standard)	International Recognition Procedure (IRP)
Approval timeline	240–480 days	60–110 days
Application fee	CLP 6,500,000	GBP 35,305
Annual renewal	CLP 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 (registered químico farmacéutico) must be designated for each pharmaceutical establishment per DS 3/2010. A Responsable de Farmacovigilancia must be designated under Norma Técnica 140 (2018) with responsibility for ICSR submission and periodic safety reports to CENIMEF.	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	Autorización Provisional / Uso de Emergencia, Vía Abreviada (Reliance fast-track)	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified by ANAMED into Modificaciones Mayores (Type II equivalent — major safety/efficacy or CMC changes), Modificaciones Menores (Type IB equivalent) and Modificaciones Administrativas (Type IA equivalent / notifications). Framework set by DS 3/2010 and complementary Normas Técnicas.	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	Registro Sanitario valid for 5 years (quinquennial). Renewal application (renovación) must be filed before expiry and includes updated quality, safety, efficacy and pharmacovigilance information.	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 Norma Técnica 140 (2018) — Sistema Nacional de Farmacovigilancia. MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted) to CENIMEF via the RAM-electronic platform, file Periodic Safety Update Reports per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics.	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	120–180 days	30–60 days
GCP standard	Norma Técnica 57 — Buenas Prácticas Clínicas (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	No	No
HTA required	Yes	Yes
HTA body	MINSAL — Departamento de Evaluación de Tecnologías Sanitarias (ETESA) and the Comisión de Recomendación Priorizada (CRP) for Ricarte Soto	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

ChileISP / ANAMED
United KingdomMHRA

English submissions

ChileNo
United KingdomYes

CTD accepted

ChileYes
United KingdomYes

eCTD accepted

ChileNo
United KingdomYes

Reliance pathway

ChileAvailable
United KingdomAvailable

Reference agencies

ChileFDA, EMA, MHRA, Swissmedic +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Registro Sanitario — Vía Ordinaria (Standard) · International Recognition Procedure (IRP)

Pathway name

ChileRegistro Sanitario — Vía Ordinaria (Standard)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Chile240–480 days
United Kingdom60–110 days

Application fee

ChileCLP 6,500,000
United KingdomGBP 35,305

Annual renewal

ChileCLP 0
United KingdomGBP 0

Local representative

ChileRequired
United KingdomNot required

Local manufacturing

ChileNot required
United KingdomNot required

GMP inspection

ChileRequired
United KingdomNot required

MAH & local presence

Local entity required

ChileYes
United KingdomYes

Local responsible person

ChileYes
United KingdomYes

RP role

ChileA Director Técnico (registered químico farmacéutico) must be designated for each pharmaceutical establishment per DS 3/2010. A Responsable de Farmacovigilancia must be designated under Norma Técnica 140 (2018) with responsibility for ICSR submission and periodic safety reports to CENIMEF.
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

Chile2 designations
United Kingdom4 designations

Examples

ChileAutorización Provisional / Uso de Emergencia, Vía Abreviada (Reliance fast-track)
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

ChileVariations classified by ANAMED into Modificaciones Mayores (Type II equivalent — major safety/efficacy or CMC changes), Modificaciones Menores (Type IB equivalent) and Modificaciones Administrativas (Type IA equivalent / notifications). Framework set by DS 3/2010 and complementary Normas Técnicas.
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

ChileRegistro Sanitario valid for 5 years (quinquennial). Renewal application (renovación) must be filed before expiry and includes updated quality, safety, efficacy and pharmacovigilance information.
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

ChilePharmacovigilance regulated by Norma Técnica 140 (2018) — Sistema Nacional de Farmacovigilancia. MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted) to CENIMEF via the RAM-electronic platform, file Periodic Safety Update Reports per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics.
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

ChileAvailable
United KingdomAvailable

Compassionate Use

ChileAvailable
United KingdomAvailable

Emergency Import

ChileAvailable
United KingdomAvailable

Parallel Import

ChileNot permitted
United KingdomPermitted

Clinical trials

CTA approval

ChileRequired
United KingdomRequired

Ethics approval

ChileYes
United KingdomYes

CTA timeline

Chile120–180 days
United Kingdom30–60 days

GCP standard

ChileNorma Técnica 57 — Buenas Prácticas Clínicas (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

ChileFree pricing
United KingdomRegulated

Reference pricing

ChileNo
United KingdomNo

HTA required

ChileYes
United KingdomYes

HTA body

ChileMINSAL — Departamento de Evaluación de Tecnologías Sanitarias (ETESA) and the Comisión de Recomendación Priorizada (CRP) for Ricarte Soto
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)