§ 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 Kingdom
Authority & dossier
Regulatory authority	Minzdrav / Roszdravnadzor	MHRA
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)	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — EAEU Mutual Recognition Procedure (MRP) · International Recognition Procedure (IRP)
Pathway name	EAEU Mutual Recognition Procedure (MRP)	International Recognition Procedure (IRP)
Approval timeline	210–365 days	60–110 days
Application fee	RUB 325,000	GBP 35,305
Annual renewal	RUB 0	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 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 (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	3 designations	4 designations
Examples	Accelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
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.	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	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; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
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.	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) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration	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	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.	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

RussiaMinzdrav / Roszdravnadzor
United KingdomMHRA

English submissions

RussiaNo
United KingdomYes

CTD accepted

RussiaYes
United KingdomYes

eCTD accepted

RussiaNo
United KingdomYes

Reliance pathway

RussiaNone
United KingdomAvailable

Reference agencies

RussiaEAEU Reference Member State (intra-EAEU only)
United KingdomFDA, EMA, Health Canada, Swissmedic +4

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

Pathway name

RussiaEAEU Mutual Recognition Procedure (MRP)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Russia210–365 days
United Kingdom60–110 days

Application fee

RussiaRUB 325,000
United KingdomGBP 35,305

Annual renewal

RussiaRUB 0
United KingdomGBP 0

Local representative

RussiaRequired
United KingdomNot required

Local manufacturing

RussiaNot required
United KingdomNot required

GMP inspection

RussiaRequired
United KingdomNot required

MAH & local presence

Local entity required

RussiaYes
United KingdomYes

Local responsible person

RussiaYes
United KingdomYes

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 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

Russia3 designations
United Kingdom4 designations

Examples

RussiaAccelerated Registration Procedure, Emergency / Pandemic Registration (Decree No. 441), Orphan Drug Designation
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

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 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

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 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

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 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

RussiaAvailable
United KingdomAvailable

Compassionate Use

RussiaAvailable
United KingdomAvailable

Emergency Import

RussiaAvailable
United KingdomAvailable

Parallel Import

RussiaPermitted
United KingdomPermitted

Clinical trials

CTA approval

RussiaRequired
United KingdomRequired

Ethics approval

RussiaYes
United KingdomYes

CTA timeline

Russia60–120 days
United Kingdom30–60 days

GCP standard

RussiaICH E6(R2) GCP (national GOST R 52379-2005); Federal Law 61-FZ; Helsinki Declaration
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

RussiaRegulated
United KingdomRegulated

Reference pricing

RussiaYes
United KingdomNo

HTA required

RussiaNo
United KingdomYes

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 KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)