§ 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 States
Authority & dossier
Regulatory authority	ISP / ANAMED	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Swissmedic +3	—
Lead pathway (timeline & fees) — Registro Sanitario — Vía Ordinaria (Standard) · New Drug Application — 505(b)(1)
Pathway name	Registro Sanitario — Vía Ordinaria (Standard)	New Drug Application — 505(b)(1)
Approval timeline	240–480 days	304–365 days
Application fee	CLP 6,500,000	USD 4,310,002
Annual renewal	CLP 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	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.	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	2 designations	6 designations
Examples	Autorización Provisional / Uso de Emergencia, Vía Abreviada (Reliance fast-track)	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
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.	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	Registro Sanitario valid for 5 years (quinquennial). Renewal application (renovación) must be filed before expiry and includes updated quality, safety, efficacy and pharmacovigilance information.	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	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.	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	120–180 days	30–30 days
GCP standard	Norma Técnica 57 — Buenas Prácticas Clínicas (aligned with ICH-GCP E6)	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Free pricing	Free pricing
Reference pricing	No	No
HTA required	Yes	No
HTA body	MINSAL — Departamento de Evaluación de Tecnologías Sanitarias (ETESA) and the Comisión de Recomendación Priorizada (CRP) for Ricarte Soto	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

ChileISP / ANAMED
United StatesFDA

English submissions

ChileNo
United StatesYes

CTD accepted

ChileYes
United StatesYes

eCTD accepted

ChileNo
United StatesYes

Reliance pathway

ChileAvailable
United StatesNone

Reference agencies

ChileFDA, EMA, MHRA, Swissmedic +3
United States—

Lead pathway (timeline & fees) — Registro Sanitario — Vía Ordinaria (Standard) · New Drug Application — 505(b)(1)

Pathway name

ChileRegistro Sanitario — Vía Ordinaria (Standard)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Chile240–480 days
United States304–365 days

Application fee

ChileCLP 6,500,000
United StatesUSD 4,310,002

Annual renewal

ChileCLP 0
United StatesUSD 416,734

Local representative

ChileRequired
United StatesNot required

Local manufacturing

ChileNot required
United StatesNot required

GMP inspection

ChileRequired
United StatesRequired

MAH & local presence

Local entity required

ChileYes
United StatesNo

Local responsible person

ChileYes
United StatesYes

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 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

Chile2 designations
United States6 designations

Examples

ChileAutorización Provisional / Uso de Emergencia, Vía Abreviada (Reliance fast-track)
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

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 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

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 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

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 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

ChileAvailable
United StatesAvailable

Compassionate Use

ChileAvailable
United StatesAvailable

Emergency Import

ChileAvailable
United StatesAvailable

Parallel Import

ChileNot permitted
United StatesNot permitted

Clinical trials

CTA approval

ChileRequired
United StatesRequired

Ethics approval

ChileYes
United StatesYes

CTA timeline

Chile120–180 days
United States30–30 days

GCP standard

ChileNorma Técnica 57 — Buenas Prácticas Clínicas (aligned with ICH-GCP E6)
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

ChileFree pricing
United StatesFree pricing

Reference pricing

ChileNo
United StatesNo

HTA required

ChileYes
United StatesNo

HTA body

ChileMINSAL — Departamento de Evaluación de Tecnologías Sanitarias (ETESA) and the Comisión de Recomendación Priorizada (CRP) for Ricarte Soto
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding