§ 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 States	🇪🇺European Union
Authority & dossier
Regulatory authority	COFEPRIS	FDA	EMA
English submissions	No	Yes	Yes
CTD accepted	Yes	Yes	Yes
eCTD accepted	Yes	Yes	Yes
Reliance pathway	Available	None	Available
Reference agencies	FDA, EMA, Health Canada, Swissmedic +5	—	—
Lead pathway (timeline & fees) — Registro Sanitario — Modalidad A (New Molecule) · New Drug Application — 505(b)(1) · Centralised Procedure
Pathway name	Registro Sanitario — Modalidad A (New Molecule)	New Drug Application — 505(b)(1)	Centralised Procedure
Approval timeline	240–365 days	304–365 days	210–277 days
Application fee	MXN 80,000	USD 4,310,002	EUR 358,800
Annual renewal	MXN 0	USD 416,734	EUR 122,500
Local representative	Required	Not required	Required
Local manufacturing	Not required	Not required	Not required
GMP inspection	Required	Required	Required
MAH & local presence
Local entity required	Yes	No	Yes
Local responsible person	Yes	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.	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.	Qualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).
Accelerated pathways
Designations available	3 designations	6 designations	6 designations
Examples	Abbreviated Pathway (July 2025 Agreement), CMN Priority Designation, Public-Health Emergency Authorisation	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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.	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.	Commission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate 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.	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.	Initial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.
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.	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.	Comprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.
Unlicensed access
Named Patient Supply	Available	Available	Available
Compassionate Use	Available	Available	Available
Emergency Import	Available	Available	Available
Parallel Import	Not permitted	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required	Required
Ethics approval	Yes	Yes	Yes
CTA timeline	60–120 days	30–30 days	60–106 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) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Free pricing	Regulated
Reference pricing	Yes	No	Yes
HTA required	Yes	No	Yes
HTA body	Centro Nacional de Excelencia Tecnológica en Salud (CENETEC) — HTA support to the Consejo de Salubridad General (CSG) for Cuadro Básico decisions	ICER (Institute for Clinical and Economic Review) — independent, non-binding	EU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

MexicoCOFEPRIS
United StatesFDA
European UnionEMA

English submissions

MexicoNo
United StatesYes
European UnionYes

CTD accepted

MexicoYes
United StatesYes
European UnionYes

eCTD accepted

MexicoYes
United StatesYes
European UnionYes

Reliance pathway

MexicoAvailable
United StatesNone
European UnionAvailable

Reference agencies

MexicoFDA, EMA, Health Canada, Swissmedic +5
United States—
European Union—

Lead pathway (timeline & fees) — Registro Sanitario — Modalidad A (New Molecule) · New Drug Application — 505(b)(1) · Centralised Procedure

Pathway name

MexicoRegistro Sanitario — Modalidad A (New Molecule)
United StatesNew Drug Application — 505(b)(1)
European UnionCentralised Procedure

Approval timeline

Mexico240–365 days
United States304–365 days
European Union210–277 days

Application fee

MexicoMXN 80,000
United StatesUSD 4,310,002
European UnionEUR 358,800

Annual renewal

MexicoMXN 0
United StatesUSD 416,734
European UnionEUR 122,500

Local representative

MexicoRequired
United StatesNot required
European UnionRequired

Local manufacturing

MexicoNot required
United StatesNot required
European UnionNot required

GMP inspection

MexicoRequired
United StatesRequired
European UnionRequired

MAH & local presence

Local entity required

MexicoYes
United StatesNo
European UnionYes

Local responsible person

MexicoYes
United StatesYes
European UnionYes

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 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.
European UnionQualified Person Responsible for Pharmacovigilance (QPPV) — must reside and operate in the EU/EEA — is responsible for the establishment and maintenance of the pharmacovigilance system. A Qualified Person (QP) in the EU/EEA performs batch certification under Article 51 of Directive 2001/83/EC. Local Contact Person for pharmacovigilance required in each Member State where the product is marketed (since 2012 GVP).

Accelerated pathways

Designations available

Mexico3 designations
United States6 designations
European Union6 designations

Examples

MexicoAbbreviated Pathway (July 2025 Agreement), CMN Priority Designation, Public-Health Emergency Authorisation
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

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 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.
European UnionCommission Regulation (EC) 1234/2008 establishes four categories: Type IA (minor — Do and Tell, 12-month notification), Type IAIN (minor — immediate notification), Type IB (minor — Tell, Wait, and Do, 30-day default), Type II (major — prior approval, 60–90 days), and Extensions (Annex I changes — full review). Worksharing procedures consolidate 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 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.
European UnionInitial 5-year renewal — application 9 months before expiry. After the first renewal, MA is granted for unlimited duration unless the CHMP/NCA, on justified grounds relating to pharmacovigilance, decides on one additional 5-year renewal.

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 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.
European UnionComprehensive PV framework under Directive 2010/84/EU and Regulation (EU) 1235/2010, codified in Good Pharmacovigilance Practices (GVP). Pharmacovigilance System Master File (PSMF) required. Periodic Safety Update Reports (PSURs) on EU-harmonised birth-date list. Risk Management Plans for all new MAs and significant variations. Suspected serious ADR reporting to EudraVigilance within 15 days. Black triangle (▼) for additional monitoring of selected products.

Unlicensed access

Named Patient Supply

MexicoAvailable
United StatesAvailable
European UnionAvailable

Compassionate Use

MexicoAvailable
United StatesAvailable
European UnionAvailable

Emergency Import

MexicoAvailable
United StatesAvailable
European UnionAvailable

Parallel Import

MexicoNot permitted
United StatesNot permitted
European UnionPermitted

Clinical trials

CTA approval

MexicoRequired
United StatesRequired
European UnionRequired

Ethics approval

MexicoYes
United StatesYes
European UnionYes

CTA timeline

Mexico60–120 days
United States30–30 days
European Union60–106 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 StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

MexicoRegulated
United StatesFree pricing
European UnionRegulated

Reference pricing

MexicoYes
United StatesNo
European UnionYes

HTA required

MexicoYes
United StatesNo
European UnionYes

HTA body

MexicoCentro Nacional de Excelencia Tecnológica en Salud (CENETEC) — HTA support to the Consejo de Salubridad General (CSG) for Cuadro Básico decisions
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)