§ 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	🇨🇴Colombia	🇺🇸United States
Authority & dossier
Regulatory authority	INVIMA	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Swissmedic +4	—
Lead pathway (timeline & fees) — Registro Sanitario — Medicamento de Síntesis Química (Standard) · New Drug Application — 505(b)(1)
Pathway name	Registro Sanitario — Medicamento de Síntesis Química (Standard)	New Drug Application — 505(b)(1)
Approval timeline	240–480 days	304–365 days
Application fee	COP 25,000,000	USD 4,310,002
Annual renewal	COP 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 or equivalent) must be designated for each establishment per Decree 677/1995. A Responsable de Farmacovigilancia must be designated under Resolución 2024015321 of 2024 with responsibility for ICSR submission and periodic safety reports.	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 Excepcional por Emergencia, Medicamento Vital No Disponible (MVND)	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations classified by INVIMA into modificaciones de seguridad y eficacia (major, requiring Sala Especializada review), modificaciones administrativas (minor, requiring INVIMA approval) and notificaciones. Decree 843 of 2016 simplified renewal and several modification procedures for chemical-synthesis medicines.	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 for chemical-synthesis medicines valid for 10 years; biologics typically 5 years. Renewal application (renovación) must be filed before expiry; Decree 843 of 2016 simplified the renewal process (presumed continuity for compliant holders).	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 Resolución 2024015321 of 2024 (replacing parts of Resolución 9455 of 2004). MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted), file Periodic Safety Update Reports per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics. Reports filed via INVIMA's e-Reporting Industria platform.	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	INVIMA Resolución 2378 of 2008 — 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	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	Instituto de Evaluación Tecnológica en Salud (IETS)	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

ColombiaINVIMA
United StatesFDA

English submissions

ColombiaNo
United StatesYes

CTD accepted

ColombiaYes
United StatesYes

eCTD accepted

ColombiaNo
United StatesYes

Reliance pathway

ColombiaAvailable
United StatesNone

Reference agencies

ColombiaFDA, EMA, MHRA, Swissmedic +4
United States—

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

Pathway name

ColombiaRegistro Sanitario — Medicamento de Síntesis Química (Standard)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Colombia240–480 days
United States304–365 days

Application fee

ColombiaCOP 25,000,000
United StatesUSD 4,310,002

Annual renewal

ColombiaCOP 0
United StatesUSD 416,734

Local representative

ColombiaRequired
United StatesNot required

Local manufacturing

ColombiaNot required
United StatesNot required

GMP inspection

ColombiaRequired
United StatesRequired

MAH & local presence

Local entity required

ColombiaYes
United StatesNo

Local responsible person

ColombiaYes
United StatesYes

RP role

ColombiaA Director Técnico (registered químico farmacéutico or equivalent) must be designated for each establishment per Decree 677/1995. A Responsable de Farmacovigilancia must be designated under Resolución 2024015321 of 2024 with responsibility for ICSR submission and periodic safety reports.
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

Colombia2 designations
United States6 designations

Examples

ColombiaAutorización Excepcional por Emergencia, Medicamento Vital No Disponible (MVND)
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

ColombiaVariations classified by INVIMA into modificaciones de seguridad y eficacia (major, requiring Sala Especializada review), modificaciones administrativas (minor, requiring INVIMA approval) and notificaciones. Decree 843 of 2016 simplified renewal and several modification procedures for chemical-synthesis medicines.
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

ColombiaRegistro Sanitario for chemical-synthesis medicines valid for 10 years; biologics typically 5 years. Renewal application (renovación) must be filed before expiry; Decree 843 of 2016 simplified the renewal process (presumed continuity for compliant holders).
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

ColombiaPharmacovigilance regulated by Resolución 2024015321 of 2024 (replacing parts of Resolución 9455 of 2004). MAHs must operate a national PV system, designate a Responsable de Farmacovigilancia, submit ICSRs (15-day for serious unlisted), file Periodic Safety Update Reports per ICH E2C(R2), and maintain Risk Management Plans for new molecules and biologics. Reports filed via INVIMA's e-Reporting Industria platform.
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

ColombiaAvailable
United StatesAvailable

Compassionate Use

ColombiaAvailable
United StatesAvailable

Emergency Import

ColombiaAvailable
United StatesAvailable

Parallel Import

ColombiaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

ColombiaRequired
United StatesRequired

Ethics approval

ColombiaYes
United StatesYes

CTA timeline

Colombia120–180 days
United States30–30 days

GCP standard

ColombiaINVIMA Resolución 2378 of 2008 — 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

ColombiaRegulated
United StatesFree pricing

Reference pricing

ColombiaYes
United StatesNo

HTA required

ColombiaYes
United StatesNo

HTA body

ColombiaInstituto de Evaluación Tecnológica en Salud (IETS)
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding