§ 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 Kingdom
Authority & dossier
Regulatory authority	INVIMA	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Swissmedic +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Registro Sanitario — Medicamento de Síntesis Química (Standard) · International Recognition Procedure (IRP)
Pathway name	Registro Sanitario — Medicamento de Síntesis Química (Standard)	International Recognition Procedure (IRP)
Approval timeline	240–480 days	60–110 days
Application fee	COP 25,000,000	GBP 35,305
Annual renewal	COP 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 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.	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 Excepcional por Emergencia, Medicamento Vital No Disponible (MVND)	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	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 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).	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 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.	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	INVIMA Resolución 2378 of 2008 — 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	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	Instituto de Evaluación Tecnológica en Salud (IETS)	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

ColombiaINVIMA
United KingdomMHRA

English submissions

ColombiaNo
United KingdomYes

CTD accepted

ColombiaYes
United KingdomYes

eCTD accepted

ColombiaNo
United KingdomYes

Reliance pathway

ColombiaAvailable
United KingdomAvailable

Reference agencies

ColombiaFDA, EMA, MHRA, Swissmedic +4
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Registro Sanitario — Medicamento de Síntesis Química (Standard) · International Recognition Procedure (IRP)

Pathway name

ColombiaRegistro Sanitario — Medicamento de Síntesis Química (Standard)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Colombia240–480 days
United Kingdom60–110 days

Application fee

ColombiaCOP 25,000,000
United KingdomGBP 35,305

Annual renewal

ColombiaCOP 0
United KingdomGBP 0

Local representative

ColombiaRequired
United KingdomNot required

Local manufacturing

ColombiaNot required
United KingdomNot required

GMP inspection

ColombiaRequired
United KingdomNot required

MAH & local presence

Local entity required

ColombiaYes
United KingdomYes

Local responsible person

ColombiaYes
United KingdomYes

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 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

Colombia2 designations
United Kingdom4 designations

Examples

ColombiaAutorización Excepcional por Emergencia, Medicamento Vital No Disponible (MVND)
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 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

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 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

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 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

ColombiaAvailable
United KingdomAvailable

Compassionate Use

ColombiaAvailable
United KingdomAvailable

Emergency Import

ColombiaAvailable
United KingdomAvailable

Parallel Import

ColombiaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

ColombiaRequired
United KingdomRequired

Ethics approval

ColombiaYes
United KingdomYes

CTA timeline

Colombia120–180 days
United Kingdom30–60 days

GCP standard

ColombiaINVIMA Resolución 2378 of 2008 — 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

ColombiaRegulated
United KingdomRegulated

Reference pricing

ColombiaYes
United KingdomNo

HTA required

ColombiaYes
United KingdomYes

HTA body

ColombiaInstituto de Evaluación Tecnológica en Salud (IETS)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)