§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	MoH / IMA	EMA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA, EMA, MHRA, Swissmedic +3	—
Lead pathway (timeline & fees) — Standard Registration (Pharmacists Regulations, 1986) · Centralised Procedure
Pathway name	Standard Registration (Pharmacists Regulations, 1986)	Centralised Procedure
Approval timeline	270–540 days	210–277 days
Application fee	ILS 60,000	EUR 358,800
Annual renewal	ILS 12,000	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	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 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	2 designations	6 designations
Examples	Express Reliance Track (2025 Reform), Emergency Use Authorisation	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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.	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	Marketing authorisation valid for 5 years (renewable). Renewal application includes updated quality, safety, efficacy and pharmacovigilance information.	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	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.	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	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/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980	ICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
HTA required	Yes	Yes
HTA body	MoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update	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

IsraelMoH / IMA
European UnionEMA

English submissions

IsraelYes
European UnionYes

CTD accepted

IsraelYes
European UnionYes

eCTD accepted

IsraelYes
European UnionYes

Reliance pathway

IsraelAvailable
European UnionAvailable

Reference agencies

IsraelFDA, EMA, MHRA, Swissmedic +3
European Union—

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

Pathway name

IsraelStandard Registration (Pharmacists Regulations, 1986)
European UnionCentralised Procedure

Approval timeline

Israel270–540 days
European Union210–277 days

Application fee

IsraelILS 60,000
European UnionEUR 358,800

Annual renewal

IsraelILS 12,000
European UnionEUR 122,500

Local representative

IsraelRequired
European UnionRequired

Local manufacturing

IsraelNot required
European UnionNot required

GMP inspection

IsraelRequired
European UnionRequired

MAH & local presence

Local entity required

IsraelYes
European UnionYes

Local responsible person

IsraelYes
European UnionYes

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.
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

Israel2 designations
European Union6 designations

Examples

IsraelExpress Reliance Track (2025 Reform), Emergency Use Authorisation
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

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.
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

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

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.
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

IsraelAvailable
European UnionAvailable

Compassionate Use

IsraelAvailable
European UnionAvailable

Emergency Import

IsraelAvailable
European UnionAvailable

Parallel Import

IsraelPermitted
European UnionPermitted

Clinical trials

CTA approval

IsraelRequired
European UnionRequired

Ethics approval

IsraelYes
European UnionYes

CTA timeline

Israel60–120 days
European Union60–106 days

GCP standard

IsraelICH E6(R2/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

IsraelRegulated
European UnionRegulated

Reference pricing

IsraelYes
European UnionYes

HTA required

IsraelYes
European UnionYes

HTA body

IsraelMoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)