§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	PPB	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +6	—
Lead pathway (timeline & fees) — New Drug Registration — Full Review · Centralised Procedure
Pathway name	New Drug Registration — Full Review	Centralised Procedure
Approval timeline	240–540 days	210–277 days
Application fee	USD 4,000	EUR 358,800
Annual renewal	USD 1,000	EUR 122,500
Local representative	Required	Required
Local manufacturing	Not required	Not required
GMP inspection	Required	Required
MAH & local presence
Local entity required	Yes	Yes
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).	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
Examples	Reliance / Abridged — Expedited Pathway, Emergency Use Authorisation (EUA), EAC Joint Assessment Procedure	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.	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	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.	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	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).	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
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	60–106 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) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	Yes
HTA required	No	Yes
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.	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

KenyaPPB
European UnionEMA

English submissions

KenyaYes
European UnionYes

CTD accepted

KenyaYes
European UnionYes

eCTD accepted

KenyaYes
European UnionYes

Reliance pathway

KenyaAvailable
European UnionAvailable

Reference agencies

KenyaFDA (US), EMA, MHRA (UK), Health Canada +6
European Union—

Lead pathway (timeline & fees) — New Drug Registration — Full Review · Centralised Procedure

Pathway name

KenyaNew Drug Registration — Full Review
European UnionCentralised Procedure

Approval timeline

Kenya240–540 days
European Union210–277 days

Application fee

KenyaUSD 4,000
European UnionEUR 358,800

Annual renewal

KenyaUSD 1,000
European UnionEUR 122,500

Local representative

KenyaRequired
European UnionRequired

Local manufacturing

KenyaNot required
European UnionNot required

GMP inspection

KenyaRequired
European UnionRequired

MAH & local presence

Local entity required

KenyaYes
European UnionYes

Local responsible person

KenyaYes
European UnionYes

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).
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

Kenya3 designations
European Union6 designations

Examples

KenyaReliance / Abridged — Expedited Pathway, Emergency Use Authorisation (EUA), EAC Joint Assessment Procedure
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.
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

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.
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

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).
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

KenyaAvailable
European UnionAvailable

Compassionate Use

KenyaAvailable
European UnionAvailable

Emergency Import

KenyaAvailable
European UnionAvailable

Parallel Import

KenyaNot permitted
European UnionPermitted

Clinical trials

CTA approval

KenyaRequired
European UnionRequired

Ethics approval

KenyaYes
European UnionYes

CTA timeline

Kenya60–120 days
European Union60–106 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
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

KenyaRegulated
European UnionRegulated

Reference pricing

KenyaNo
European UnionYes

HTA required

KenyaNo
European UnionYes

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.
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)