§ 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	🇰🇪Kenya	🇺🇸United States
Authority & dossier
Regulatory authority	PPB	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +6	—
Lead pathway (timeline & fees) — New Drug Registration — Full Review · New Drug Application — 505(b)(1)
Pathway name	New Drug Registration — Full Review	New Drug Application — 505(b)(1)
Approval timeline	240–540 days	304–365 days
Application fee	USD 4,000	USD 4,310,002
Annual renewal	USD 1,000	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 LTR must employ a Superintendent Pharmacist registered with PPB, and designate a Qualified Person for Pharmacovigilance (QPPV) as the contact for the PPB Pharmacovigilance Directorate and the Pharmacovigilance Electronic Reporting System (PvERS).	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 Authorisation (EUA), EAC Joint Assessment Procedure	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations are classified per PPB / EAC harmonised variation guidelines (broadly aligned with WHO and EU practice) into Minor (notification or prior-approval), Major (prior-approval) and Extensions of registration. PPB is progressively aligning its variations framework with WHO/EU classification as part of its ML3 maintenance 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	PPB Certificate of Product 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 PPB Pharmacovigilance & Clinical Trials Directorate coordinates national ADR reporting; Kenya is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2010). MAHs / LTRs 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. PPB operates the Pharmacovigilance Electronic Reporting System (PvERS) and the Med Safety mobile app (in partnership with WHO and the Uppsala Monitoring Centre).	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; PPB Guidelines for the Conduct of Clinical Trials; National Commission for Science, Technology & Innovation (NACOSTI) research licence; Helsinki Declaration	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	No	No
HTA required	No	No
HTA body	No formal national HTA agency; HTA capacity is being developed within the Ministry of Health, the Social Health Authority (SHA) and the Kenya Medical Research Institute (KEMRI) 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

KenyaPPB
United StatesFDA

English submissions

KenyaYes
United StatesYes

CTD accepted

KenyaYes
United StatesYes

eCTD accepted

KenyaYes
United StatesYes

Reliance pathway

KenyaAvailable
United StatesNone

Reference agencies

KenyaFDA (US), EMA, MHRA (UK), Health Canada +6
United States—

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

Pathway name

KenyaNew Drug Registration — Full Review
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Kenya240–540 days
United States304–365 days

Application fee

KenyaUSD 4,000
United StatesUSD 4,310,002

Annual renewal

KenyaUSD 1,000
United StatesUSD 416,734

Local representative

KenyaRequired
United StatesNot required

Local manufacturing

KenyaNot required
United StatesNot required

GMP inspection

KenyaRequired
United StatesRequired

MAH & local presence

Local entity required

KenyaYes
United StatesNo

Local responsible person

KenyaYes
United StatesYes

RP role

KenyaThe LTR must employ a Superintendent Pharmacist registered with PPB, and designate a Qualified Person for Pharmacovigilance (QPPV) as the contact for the PPB Pharmacovigilance Directorate and the Pharmacovigilance Electronic Reporting System (PvERS).
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

Kenya3 designations
United States6 designations

Examples

KenyaReliance / Abridged — Expedited Pathway, Emergency Use Authorisation (EUA), EAC Joint Assessment Procedure
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

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

KenyaPPB Certificate of Product 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

KenyaThe PPB Pharmacovigilance & Clinical Trials Directorate coordinates national ADR reporting; Kenya is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2010). MAHs / LTRs 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. PPB operates the Pharmacovigilance Electronic Reporting System (PvERS) and the Med Safety mobile app (in partnership with WHO and the Uppsala Monitoring Centre).
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

KenyaAvailable
United StatesAvailable

Compassionate Use

KenyaAvailable
United StatesAvailable

Emergency Import

KenyaAvailable
United StatesAvailable

Parallel Import

KenyaNot permitted
United StatesNot permitted

Clinical trials

CTA approval

KenyaRequired
United StatesRequired

Ethics approval

KenyaYes
United StatesYes

CTA timeline

Kenya60–120 days
United States30–30 days

GCP standard

KenyaICH E6(R2) GCP; PPB Guidelines for the Conduct of Clinical Trials; National Commission for Science, Technology & Innovation (NACOSTI) research licence; Helsinki Declaration
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

KenyaRegulated
United StatesFree pricing

Reference pricing

KenyaNo
United StatesNo

HTA required

KenyaNo
United StatesNo

HTA body

KenyaNo formal national HTA agency; HTA capacity is being developed within the Ministry of Health, the Social Health Authority (SHA) and the Kenya Medical Research Institute (KEMRI) under universal health coverage reforms.
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding