§ 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
Authority & dossier
Regulatory authority	COFEPRIS	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, Health Canada, Swissmedic +5	—
Lead pathway (timeline & fees) — Registro Sanitario — Modalidad A (New Molecule) · New Drug Application — 505(b)(1)
Pathway name	Registro Sanitario — Modalidad A (New Molecule)	New Drug Application — 505(b)(1)
Approval timeline	240–365 days	304–365 days
Application fee	MXN 80,000	USD 4,310,002
Annual renewal	MXN 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 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.
Accelerated pathways
Designations available	3 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
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.
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.
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.
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	60–120 days	30–30 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
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
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

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

Authority & dossier

Regulatory authority

MexicoCOFEPRIS
United StatesFDA

English submissions

MexicoNo
United StatesYes

CTD accepted

MexicoYes
United StatesYes

eCTD accepted

MexicoYes
United StatesYes

Reliance pathway

MexicoAvailable
United StatesNone

Reference agencies

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

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

Pathway name

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

Approval timeline

Mexico240–365 days
United States304–365 days

Application fee

MexicoMXN 80,000
United StatesUSD 4,310,002

Annual renewal

MexicoMXN 0
United StatesUSD 416,734

Local representative

MexicoRequired
United StatesNot required

Local manufacturing

MexicoNot required
United StatesNot required

GMP inspection

MexicoRequired
United StatesRequired

MAH & local presence

Local entity required

MexicoYes
United StatesNo

Local responsible person

MexicoYes
United StatesYes

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.

Accelerated pathways

Designations available

Mexico3 designations
United States6 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

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.

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.

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.

Unlicensed access

Named Patient Supply

MexicoAvailable
United StatesAvailable

Compassionate Use

MexicoAvailable
United StatesAvailable

Emergency Import

MexicoAvailable
United StatesAvailable

Parallel Import

MexicoNot permitted
United StatesNot permitted

Clinical trials

CTA approval

MexicoRequired
United StatesRequired

Ethics approval

MexicoYes
United StatesYes

CTA timeline

Mexico60–120 days
United States30–30 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

Pricing & reimbursement

Price regulation

MexicoRegulated
United StatesFree pricing

Reference pricing

MexicoYes
United StatesNo

HTA required

MexicoYes
United StatesNo

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