§ 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	🇷🇺Russia	🇺🇸United States
Authority & dossier
Regulatory authority	Minzdrav / Roszdravnadzor	FDA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	None	None
Reference agencies	EAEU Reference Member State (intra-EAEU only)	—
Lead pathway (timeline & fees) — EAEU Mutual Recognition Procedure (MRP) · New Drug Application — 505(b)(1)
Pathway name	EAEU Mutual Recognition Procedure (MRP)	New Drug Application — 505(b)(1)
Approval timeline	210–365 days	304–365 days
Application fee	RUB 325,000	USD 4,310,002
Annual renewal	RUB 0	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 Authorised Person for Pharmacovigilance (Upolnomochennoye litso po farmakonadzoru), who is the contact for Roszdravnadzor's Pharmacovigilance Department and the Federal Centre for Monitoring of Safety of Medicines. Russian-language ADR reporting is required via the AIS Roszdravnadzora Farmakonadzor 2.0 system.	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	3 designations	6 designations
Examples	Accelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation	Priority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3
Post-approval lifecycle
Variations framework	Variations are classified under EAEU rules into Type IA (notification), Type IB (tell-wait-do), Type II (prior approval), and Extensions, broadly mirroring EU classification but with Russian / EAEU specifics. National Russian variations procedure under Federal Law 61-FZ and Decree No. 1314 applies for pre-EAEU RUs during the transition.	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	Russian RU is initially valid for 5 years, then becomes indefinite (without expiry) on first renewal subject to favourable benefit/risk and submission of a renewal dossier. EAEU MAs follow EAEU renewal rules.	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	Roszdravnadzor's Pharmacovigilance Department coordinates national ADR reporting through the AIS Roszdravnadzora Farmakonadzor 2.0 electronic system. Russia is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 1997). MAHs must submit Periodic Safety Update Reports (PSURs / PBRER aligned to ICH E2C(R2)), report serious unexpected ADRs within 15 days, and maintain a Risk Management Plan (RMP) for new active substances and vaccines.	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) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration	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	No	No
HTA body	Centre for Healthcare Quality Assessment and Control (TsEKKMP) under Minzdrav performs comparative clinical / pharmacoeconomic assessment for ZhNVLP listing decisions and federal procurement; not a fully autonomous HTA agency.	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

RussiaMinzdrav / Roszdravnadzor
United StatesFDA

English submissions

RussiaNo
United StatesYes

CTD accepted

RussiaYes
United StatesYes

eCTD accepted

RussiaNo
United StatesYes

Reliance pathway

RussiaNone
United StatesNone

Reference agencies

RussiaEAEU Reference Member State (intra-EAEU only)
United States—

Lead pathway (timeline & fees) — EAEU Mutual Recognition Procedure (MRP) · New Drug Application — 505(b)(1)

Pathway name

RussiaEAEU Mutual Recognition Procedure (MRP)
United StatesNew Drug Application — 505(b)(1)

Approval timeline

Russia210–365 days
United States304–365 days

Application fee

RussiaRUB 325,000
United StatesUSD 4,310,002

Annual renewal

RussiaRUB 0
United StatesUSD 416,734

Local representative

RussiaRequired
United StatesNot required

Local manufacturing

RussiaNot required
United StatesNot required

GMP inspection

RussiaRequired
United StatesRequired

MAH & local presence

Local entity required

RussiaYes
United StatesNo

Local responsible person

RussiaYes
United StatesYes

RP role

RussiaEach MA holder must designate an Authorised Person for Pharmacovigilance (Upolnomochennoye litso po farmakonadzoru), who is the contact for Roszdravnadzor's Pharmacovigilance Department and the Federal Centre for Monitoring of Safety of Medicines. Russian-language ADR reporting is required via the AIS Roszdravnadzora Farmakonadzor 2.0 system.
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

Russia3 designations
United States6 designations

Examples

RussiaAccelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation
United StatesPriority Review, Breakthrough Therapy Designation, Accelerated Approval — Subpart H/E +3

Post-approval lifecycle

Variations framework

RussiaVariations are classified under EAEU rules into Type IA (notification), Type IB (tell-wait-do), Type II (prior approval), and Extensions, broadly mirroring EU classification but with Russian / EAEU specifics. National Russian variations procedure under Federal Law 61-FZ and Decree No. 1314 applies for pre-EAEU RUs during the transition.
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

RussiaRussian RU is initially valid for 5 years, then becomes indefinite (without expiry) on first renewal subject to favourable benefit/risk and submission of a renewal dossier. EAEU MAs follow EAEU renewal rules.
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

RussiaRoszdravnadzor's Pharmacovigilance Department coordinates national ADR reporting through the AIS Roszdravnadzora Farmakonadzor 2.0 electronic system. Russia is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 1997). MAHs must submit Periodic Safety Update Reports (PSURs / PBRER aligned to ICH E2C(R2)), report serious unexpected ADRs within 15 days, and maintain a Risk Management Plan (RMP) for new active substances and vaccines.
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

RussiaAvailable
United StatesAvailable

Compassionate Use

RussiaAvailable
United StatesAvailable

Emergency Import

RussiaAvailable
United StatesAvailable

Parallel Import

RussiaPermitted
United StatesNot permitted

Clinical trials

CTA approval

RussiaRequired
United StatesRequired

Ethics approval

RussiaYes
United StatesYes

CTA timeline

Russia60–120 days
United States30–30 days

GCP standard

RussiaICH E6(R2) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration
United StatesICH E6(R3) (adopted via FDA guidance January 2025); 21 CFR 312, 314, 50, 56

Pricing & reimbursement

Price regulation

RussiaRegulated
United StatesFree pricing

Reference pricing

RussiaYes
United StatesNo

HTA required

RussiaNo
United StatesNo

HTA body

RussiaCentre for Healthcare Quality Assessment and Control (TsEKKMP) under Minzdrav performs comparative clinical / pharmacoeconomic assessment for ZhNVLP listing decisions and federal procurement; not a fully autonomous HTA agency.
United StatesICER (Institute for Clinical and Economic Review) — independent, non-binding