§ 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	🇳🇬Nigeria	🇺🇸United States
Authority & dossier
Regulatory authority	NAFDAC	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	None
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	—
Lead pathway (timeline & fees) — New Drug Registration — Standard Review · New Drug Application — 505(b)(1)
Pathway name	New Drug Registration — Standard Review	New Drug Application — 505(b)(1)
Approval timeline	270–540 days	304–365 days
Application fee	USD 5,000	USD 4,310,002
Annual renewal	USD 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	The local representative must employ a Superintendent Pharmacist registered with the Pharmacy Council of Nigeria (PCN), and designate a Qualified Person for Pharmacovigilance (QPPV) as the contact for the NAFDAC Pharmacovigilance and Post-Marketing Surveillance Directorate.	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	Reliance / Abridged — Expedited Pathway, Emergency Use Listing / Authorisation (EUL / EUA), Priority Review — Public Health Need	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations are classified per NAFDAC variation guidelines (broadly aligned with WHO and EU practice) into Minor (notification or prior-approval), Major (prior-approval) and Extensions of registration. NAFDAC is progressively aligning its variations framework with WHO/EU classification as part of its ML3 work.	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	NAFDAC Certificate of Registration is valid for 5 years and renewable for further 5-year periods; renewal requires up-to-date CMC, safety, GMP and labelling information, plus payment of renewal fees.	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	The NAFDAC Pharmacovigilance and Post-Marketing Surveillance Directorate coordinates national ADR reporting; Nigeria is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2004). MAHs / local representatives must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines (15 days for serious unexpected ADRs), and maintain a Risk Management Plan (RMP) for new active substances and vaccines. NAFDAC operates the Med-Safety mobile app for ADR reporting.	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 E6(R2) GCP; NAFDAC Clinical Trial Guidelines; National Code of Health Research Ethics (NHREC); Helsinki Declaration	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Free pricing	Free pricing
Reference pricing	No	No
HTA required	No	No
HTA body	No formal national HTA agency; HTA capacity is being developed within the Federal Ministry of Health and the National Health Insurance Authority (NHIA) under universal health coverage reforms.	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

NigeriaNAFDAC
United StatesFDA

English submissions

NigeriaYes
United StatesYes

CTD accepted

NigeriaYes
United StatesYes

eCTD accepted

NigeriaNo
United StatesYes

Reliance pathway

NigeriaAvailable
United StatesNone

Reference agencies

NigeriaFDA (US), EMA, MHRA (UK), Health Canada +4
United States—

Lead pathway (timeline & fees) — New Drug Registration — Standard Review · New Drug Application — 505(b)(1)

Pathway name

NigeriaNew Drug Registration — Standard Review
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Nigeria270–540 days
United States304–365 days

Application fee

NigeriaUSD 5,000
United StatesUSD 4,310,002

Annual renewal

NigeriaUSD 0
United StatesUSD 416,734

Local representative

NigeriaRequired
United StatesNot required

Local manufacturing

NigeriaNot required
United StatesNot required

GMP inspection

NigeriaRequired
United StatesRequired

MAH & local presence

Local entity required

NigeriaYes
United StatesNo

Local responsible person

NigeriaYes
United StatesYes

RP role

NigeriaThe local representative must employ a Superintendent Pharmacist registered with the Pharmacy Council of Nigeria (PCN), and designate a Qualified Person for Pharmacovigilance (QPPV) as the contact for the NAFDAC Pharmacovigilance and Post-Marketing Surveillance Directorate.
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

Nigeria3 designations
United States6 designations

Examples

NigeriaReliance / Abridged — Expedited Pathway, Emergency Use Listing / Authorisation (EUL / EUA), Priority Review — Public Health Need
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

NigeriaVariations are classified per NAFDAC variation guidelines (broadly aligned with WHO and EU practice) into Minor (notification or prior-approval), Major (prior-approval) and Extensions of registration. NAFDAC is progressively aligning its variations framework with WHO/EU classification as part of its ML3 work.
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

NigeriaNAFDAC Certificate of Registration is valid for 5 years and renewable for further 5-year periods; renewal requires up-to-date CMC, safety, GMP and labelling information, plus payment of renewal fees.
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

NigeriaThe NAFDAC Pharmacovigilance and Post-Marketing Surveillance Directorate coordinates national ADR reporting; Nigeria is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2004). MAHs / local representatives must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines (15 days for serious unexpected ADRs), and maintain a Risk Management Plan (RMP) for new active substances and vaccines. NAFDAC operates the Med-Safety mobile app for ADR reporting.
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

NigeriaAvailable
United StatesAvailable

Compassionate Use

NigeriaAvailable
United StatesAvailable

Emergency Import

NigeriaAvailable
United StatesAvailable

Parallel Import

NigeriaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

NigeriaRequired
United StatesRequired

Ethics approval

NigeriaYes
United StatesYes

CTA timeline

Nigeria60–120 days
United States30–30 days

GCP standard

NigeriaICH E6(R2) GCP; NAFDAC Clinical Trial Guidelines; National Code of Health Research Ethics (NHREC); Helsinki Declaration
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

NigeriaFree pricing
United StatesFree pricing

Reference pricing

NigeriaNo
United StatesNo

HTA required

NigeriaNo
United StatesNo

HTA body

NigeriaNo formal national HTA agency; HTA capacity is being developed within the Federal Ministry of Health and the National Health Insurance Authority (NHIA) under universal health coverage reforms.
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding