§ 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 Kingdom
Authority & dossier
Regulatory authority	PPB	MHRA
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	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — New Drug Registration — Full Review · International Recognition Procedure (IRP)
Pathway name	New Drug Registration — Full Review	International Recognition Procedure (IRP)
Approval timeline	240–540 days	60–110 days
Application fee	USD 4,000	GBP 35,305
Annual renewal	USD 1,000	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not 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 (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	3 designations	4 designations
Examples	Reliance / Abridged — Expedited Pathway, Emergency Use Authorisation (EUA), EAC Joint Assessment Procedure	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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).	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
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	30–60 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) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	No
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.	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

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

Authority & dossier

Regulatory authority

KenyaPPB
United KingdomMHRA

English submissions

KenyaYes
United KingdomYes

CTD accepted

KenyaYes
United KingdomYes

eCTD accepted

KenyaYes
United KingdomYes

Reliance pathway

KenyaAvailable
United KingdomAvailable

Reference agencies

KenyaFDA (US), EMA, MHRA (UK), Health Canada +6
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — New Drug Registration — Full Review · International Recognition Procedure (IRP)

Pathway name

KenyaNew Drug Registration — Full Review
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Kenya240–540 days
United Kingdom60–110 days

Application fee

KenyaUSD 4,000
United KingdomGBP 35,305

Annual renewal

KenyaUSD 1,000
United KingdomGBP 0

Local representative

KenyaRequired
United KingdomNot required

Local manufacturing

KenyaNot required
United KingdomNot required

GMP inspection

KenyaRequired
United KingdomNot required

MAH & local presence

Local entity required

KenyaYes
United KingdomYes

Local responsible person

KenyaYes
United KingdomYes

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 KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Kenya3 designations
United Kingdom4 designations

Examples

KenyaReliance / Abridged — Expedited Pathway, Emergency Use Authorisation (EUA), EAC Joint Assessment Procedure
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped 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.
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

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 KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

KenyaAvailable
United KingdomAvailable

Compassionate Use

KenyaAvailable
United KingdomAvailable

Emergency Import

KenyaAvailable
United KingdomAvailable

Parallel Import

KenyaNot permitted
United KingdomPermitted

Clinical trials

CTA approval

KenyaRequired
United KingdomRequired

Ethics approval

KenyaYes
United KingdomYes

CTA timeline

Kenya60–120 days
United Kingdom30–60 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 KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

KenyaRegulated
United KingdomRegulated

Reference pricing

KenyaNo
United KingdomNo

HTA required

KenyaNo
United KingdomYes

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 KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)