§ 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	🇲🇽Mexico	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	COFEPRIS	MHRA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, Health Canada, Swissmedic +5	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Registro Sanitario — Modalidad A (New Molecule) · International Recognition Procedure (IRP)
Pathway name	Registro Sanitario — Modalidad A (New Molecule)	International Recognition Procedure (IRP)
Approval timeline	240–365 days	60–110 days
Application fee	MXN 80,000	GBP 35,305
Annual renewal	MXN 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 Responsable Sanitario (Sanitary Responsible — typically a licensed pharmacist or QFB) must be designated and listed in the Aviso de Responsable Sanitario. A separate Responsable de Farmacovigilancia (RFV) must be designated under NOM-220-SSA1-2016 with their own Aviso filed with COFEPRIS.	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	3 designations	4 designations
Examples	Abbreviated Pathway (July 2025 Agreement), CMN Priority Designation, Public-Health Emergency Authorisation	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Modificaciones a las Condiciones de Registro Sanitario classified by COFEPRIS into administrative, technical (minor and major), and notifications. Major technical changes (manufacturing site, formulation, indication) require COFEPRIS approval; minor changes follow a notification procedure.	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; renewal application (prórroga) must be filed within the 150 calendar days before expiry per RIS Article 376. Renewal requires updated safety information, marketing status confirmation 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 NOM-220-SSA1-2016 and its 2020 amendment. Mandatory ICSR reporting to COFEPRIS (15-day for serious unlisted, periodic for others), PSUR/PBRER per ICH E2C(R2), Risk Management Plan for new molecules and biocomparables, and an in-country Responsable de Farmacovigilancia. Mexico 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	60–120 days	30–60 days
GCP standard	ICH-GCP E6(R2); aligned with Mexican Reglamento de la Ley General de Salud en Materia de Investigación para la Salud	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	Centro Nacional de Excelencia Tecnológica en Salud (CENETEC) — HTA support to the Consejo de Salubridad General (CSG) for Cuadro Básico decisions	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

MexicoCOFEPRIS
United KingdomMHRA

English submissions

MexicoNo
United KingdomYes

CTD accepted

MexicoYes
United KingdomYes

eCTD accepted

MexicoYes
United KingdomYes

Reliance pathway

MexicoAvailable
United KingdomAvailable

Reference agencies

MexicoFDA, EMA, Health Canada, Swissmedic +5
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Registro Sanitario — Modalidad A (New Molecule) · International Recognition Procedure (IRP)

Pathway name

MexicoRegistro Sanitario — Modalidad A (New Molecule)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Mexico240–365 days
United Kingdom60–110 days

Application fee

MexicoMXN 80,000
United KingdomGBP 35,305

Annual renewal

MexicoMXN 0
United KingdomGBP 0

Local representative

MexicoRequired
United KingdomNot required

Local manufacturing

MexicoNot required
United KingdomNot required

GMP inspection

MexicoRequired
United KingdomNot required

MAH & local presence

Local entity required

MexicoYes
United KingdomYes

Local responsible person

MexicoYes
United KingdomYes

RP role

MexicoA Responsable Sanitario (Sanitary Responsible — typically a licensed pharmacist or QFB) must be designated and listed in the Aviso de Responsable Sanitario. A separate Responsable de Farmacovigilancia (RFV) must be designated under NOM-220-SSA1-2016 with their own Aviso filed with COFEPRIS.
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

Mexico3 designations
United Kingdom4 designations

Examples

MexicoAbbreviated Pathway (July 2025 Agreement), CMN Priority Designation, Public-Health Emergency Authorisation
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

MexicoModificaciones a las Condiciones de Registro Sanitario classified by COFEPRIS into administrative, technical (minor and major), and notifications. Major technical changes (manufacturing site, formulation, indication) require COFEPRIS approval; minor changes follow a notification procedure.
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

MexicoRegistro Sanitario valid for 5 years; renewal application (prórroga) must be filed within the 150 calendar days before expiry per RIS Article 376. Renewal requires updated safety information, marketing status confirmation 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

MexicoPharmacovigilance regulated by NOM-220-SSA1-2016 and its 2020 amendment. Mandatory ICSR reporting to COFEPRIS (15-day for serious unlisted, periodic for others), PSUR/PBRER per ICH E2C(R2), Risk Management Plan for new molecules and biocomparables, and an in-country Responsable de Farmacovigilancia. Mexico 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

MexicoAvailable
United KingdomAvailable

Compassionate Use

MexicoAvailable
United KingdomAvailable

Emergency Import

MexicoAvailable
United KingdomAvailable

Parallel Import

MexicoNot permitted
United KingdomPermitted

Clinical trials

CTA approval

MexicoRequired
United KingdomRequired

Ethics approval

MexicoYes
United KingdomYes

CTA timeline

Mexico60–120 days
United Kingdom30–60 days

GCP standard

MexicoICH-GCP E6(R2); aligned with Mexican Reglamento de la Ley General de Salud en Materia de Investigación para la Salud
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

MexicoRegulated
United KingdomRegulated

Reference pricing

MexicoYes
United KingdomNo

HTA required

MexicoYes
United KingdomYes

HTA body

MexicoCentro Nacional de Excelencia Tecnológica en Salud (CENETEC) — HTA support to the Consejo de Salubridad General (CSG) for Cuadro Básico decisions
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)