§ 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	🇮🇱Israel	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	MoH / IMA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Swissmedic +3	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Standard Registration (Pharmacists Regulations, 1986) · International Recognition Procedure (IRP)
Pathway name	Standard Registration (Pharmacists Regulations, 1986)	International Recognition Procedure (IRP)
Approval timeline	270–540 days	60–110 days
Application fee	ILS 60,000	GBP 35,305
Annual renewal	ILS 12,000	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	Each MA holder must designate an Israeli Pharmacovigilance Contact Person (PVCP) and a Responsible Pharmacist (Rokeach Achrai) for regulatory and quality matters. PV obligations are aligned with EU/ICH E2C and E2D.	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	2 designations	4 designations
Examples	Express Reliance Track (2025 Reform), Emergency Use Authorisation	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified by the MoH Pharmaceutical Administration into Major (Type II equivalent), Minor (Type IB equivalent) and Notifications (Type IA equivalent), broadly aligned with the EU framework. Reliance applies to variations already approved by a recognised regulator.	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	Marketing authorisation valid for 5 years (renewable). Renewal application includes updated quality, safety, efficacy and pharmacovigilance information.	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	Pharmacovigilance regulated by MoH Procedure (Nohal) for PV and aligned with ICH E2A–E2F. MA holders must operate a national PV system, appoint a PVCP, submit ICSRs (15-day for serious unlisted) via the MoH PV reporting system, file PSURs per ICH E2C(R2), and maintain RMPs for new molecules and biologics.	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	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/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980	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	Yes	No
HTA required	Yes	Yes
HTA body	MoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update	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

IsraelMoH / IMA
United KingdomMHRA

English submissions

IsraelYes
United KingdomYes

CTD accepted

IsraelYes
United KingdomYes

eCTD accepted

IsraelYes
United KingdomYes

Reliance pathway

IsraelAvailable
United KingdomAvailable

Reference agencies

IsraelFDA, EMA, MHRA, Swissmedic +3
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Standard Registration (Pharmacists Regulations, 1986) · International Recognition Procedure (IRP)

Pathway name

IsraelStandard Registration (Pharmacists Regulations, 1986)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Israel270–540 days
United Kingdom60–110 days

Application fee

IsraelILS 60,000
United KingdomGBP 35,305

Annual renewal

IsraelILS 12,000
United KingdomGBP 0

Local representative

IsraelRequired
United KingdomNot required

Local manufacturing

IsraelNot required
United KingdomNot required

GMP inspection

IsraelRequired
United KingdomNot required

MAH & local presence

Local entity required

IsraelYes
United KingdomYes

Local responsible person

IsraelYes
United KingdomYes

RP role

IsraelEach MA holder must designate an Israeli Pharmacovigilance Contact Person (PVCP) and a Responsible Pharmacist (Rokeach Achrai) for regulatory and quality matters. PV obligations are aligned with EU/ICH E2C and E2D.
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

Israel2 designations
United Kingdom4 designations

Examples

IsraelExpress Reliance Track (2025 Reform), Emergency Use Authorisation
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

IsraelVariations classified by the MoH Pharmaceutical Administration into Major (Type II equivalent), Minor (Type IB equivalent) and Notifications (Type IA equivalent), broadly aligned with the EU framework. Reliance applies to variations already approved by a recognised regulator.
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

IsraelMarketing authorisation valid for 5 years (renewable). Renewal application includes updated quality, safety, efficacy and pharmacovigilance information.
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

IsraelPharmacovigilance regulated by MoH Procedure (Nohal) for PV and aligned with ICH E2A–E2F. MA holders must operate a national PV system, appoint a PVCP, submit ICSRs (15-day for serious unlisted) via the MoH PV reporting system, file PSURs per ICH E2C(R2), and maintain RMPs for new molecules and biologics.
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

IsraelAvailable
United KingdomAvailable

Compassionate Use

IsraelAvailable
United KingdomAvailable

Emergency Import

IsraelAvailable
United KingdomAvailable

Parallel Import

IsraelPermitted
United KingdomPermitted

Clinical trials

CTA approval

IsraelRequired
United KingdomRequired

Ethics approval

IsraelYes
United KingdomYes

CTA timeline

Israel60–120 days
United Kingdom30–60 days

GCP standard

IsraelICH E6(R2/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

IsraelRegulated
United KingdomRegulated

Reference pricing

IsraelYes
United KingdomNo

HTA required

IsraelYes
United KingdomYes

HTA body

IsraelMoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)