§ 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 States
Authority & dossier
Regulatory authority	MoH / IMA	FDA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	None
Reference agencies	FDA, EMA, MHRA, Swissmedic +3	—
Lead pathway (timeline & fees) — Standard Registration (Pharmacists Regulations, 1986) · New Drug Application — 505(b)(1)
Pathway name	Standard Registration (Pharmacists Regulations, 1986)	New Drug Application — 505(b)(1)
Approval timeline	270–540 days	304–365 days
Application fee	ILS 60,000	USD 4,310,002
Annual renewal	ILS 12,000	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	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.	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	2 designations	6 designations
Examples	Express Reliance Track (2025 Reform), Emergency Use Authorisation	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +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.	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	Marketing authorisation valid for 5 years (renewable). Renewal application includes updated quality, safety, efficacy and pharmacovigilance information.	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	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.	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	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/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980	ICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56
Pricing & reimbursement
Price regulation	Regulated	Free pricing
Reference pricing	Yes	No
HTA required	Yes	No
HTA body	MoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update	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

IsraelMoH / IMA
United StatesFDA

English submissions

IsraelYes
United StatesYes

CTD accepted

IsraelYes
United StatesYes

eCTD accepted

IsraelYes
United StatesYes

Reliance pathway

IsraelAvailable
United StatesNone

Reference agencies

IsraelFDA, EMA, MHRA, Swissmedic +3
United States—

Lead pathway (timeline & fees) — Standard Registration (Pharmacists Regulations, 1986) · New Drug Application — 505(b)(1)

Pathway name

IsraelStandard Registration (Pharmacists Regulations, 1986)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Israel270–540 days
United States304–365 days

Application fee

IsraelILS 60,000
United StatesUSD 4,310,002

Annual renewal

IsraelILS 12,000
United StatesUSD 416,734

Local representative

IsraelRequired
United StatesNot required

Local manufacturing

IsraelNot required
United StatesNot required

GMP inspection

IsraelRequired
United StatesRequired

MAH & local presence

Local entity required

IsraelYes
United StatesNo

Local responsible person

IsraelYes
United StatesYes

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 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

Israel2 designations
United States6 designations

Examples

IsraelExpress Reliance Track (2025 Reform), Emergency Use Authorisation
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +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.
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

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

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 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

IsraelAvailable
United StatesAvailable

Compassionate Use

IsraelAvailable
United StatesAvailable

Emergency Import

IsraelAvailable
United StatesAvailable

Parallel Import

IsraelPermitted
United StatesNot permitted

Clinical trials

CTA approval

IsraelRequired
United StatesRequired

Ethics approval

IsraelYes
United StatesYes

CTA timeline

Israel60–120 days
United States30–30 days

GCP standard

IsraelICH E6(R2/R3) GCP; Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

IsraelRegulated
United StatesFree pricing

Reference pricing

IsraelYes
United StatesNo

HTA required

IsraelYes
United StatesNo

HTA body

IsraelMoH Drug Basket Committee (Va'adat Sal HaTrufot) — annual Health Basket update
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding