§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	Minzdrav / Roszdravnadzor	EMA
English submissions	No	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	None	Available
Reference agencies	EAEU Reference Member State (intra-EAEU only)	—
Lead pathway (timeline & fees) — EAEU Mutual Recognition Procedure (MRP) · Centralised Procedure
Pathway name	EAEU Mutual Recognition Procedure (MRP)	Centralised Procedure
Approval timeline	210–365 days	210–277 days
Application fee	RUB 325,000	EUR 358,800
Annual renewal	RUB 0	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 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.	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	3 designations	6 designations
Examples	Accelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.	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	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.	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	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.	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) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration	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	No	Yes
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.	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

RussiaMinzdrav / Roszdravnadzor
European UnionEMA

English submissions

RussiaNo
European UnionYes

CTD accepted

RussiaYes
European UnionYes

eCTD accepted

RussiaNo
European UnionYes

Reliance pathway

RussiaNone
European UnionAvailable

Reference agencies

RussiaEAEU Reference Member State (intra-EAEU only)
European Union—

Lead pathway (timeline & fees) — EAEU Mutual Recognition Procedure (MRP) · Centralised Procedure

Pathway name

RussiaEAEU Mutual Recognition Procedure (MRP)
European UnionCentralised Procedure

Approval timeline

Russia210–365 days
European Union210–277 days

Application fee

RussiaRUB 325,000
European UnionEUR 358,800

Annual renewal

RussiaRUB 0
European UnionEUR 122,500

Local representative

RussiaRequired
European UnionRequired

Local manufacturing

RussiaNot required
European UnionNot required

GMP inspection

RussiaRequired
European UnionRequired

MAH & local presence

Local entity required

RussiaYes
European UnionYes

Local responsible person

RussiaYes
European UnionYes

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.
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

Russia3 designations
European Union6 designations

Examples

RussiaAccelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +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.
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

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.
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

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.
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

RussiaAvailable
European UnionAvailable

Compassionate Use

RussiaAvailable
European UnionAvailable

Emergency Import

RussiaAvailable
European UnionAvailable

Parallel Import

RussiaPermitted
European UnionPermitted

Clinical trials

CTA approval

RussiaRequired
European UnionRequired

Ethics approval

RussiaYes
European UnionYes

CTA timeline

Russia60–120 days
European Union60–106 days

GCP standard

RussiaICH E6(R2) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

RussiaRegulated
European UnionRegulated

Reference pricing

RussiaYes
European UnionYes

HTA required

RussiaNo
European UnionYes

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.
European UnionEU HTA Coordination Group (EUnetHTA legacy); national HTA bodies (NICE, HAS, G-BA/IQWiG, AIFA, AEMPS, etc.)