§ 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	🇺🇦Ukraine	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	MOZ / SEC	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — National Procedure (Standard) · International Recognition Procedure (IRP)
Pathway name	National Procedure (Standard)	International Recognition Procedure (IRP)
Approval timeline	210–365 days	60–110 days
Application fee	UAH 100,000	GBP 35,305
Annual renewal	UAH 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 a Qualified Person for Pharmacovigilance (Upovnovazhena Osoba z Farmakonahliadu) — Ukraine-resident, registered with SEC, accountable for ADR reporting via the SEC AISF (Automated Information System for Pharmacovigilance) electronic system. PSURs aligned to ICH E2C(R2) submitted to SEC per the EURD-equivalent national list.	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	4 designations	4 designations
Examples	Wartime Simplified Procedure (Resolution 376, 2022), Abridged Procedure (Order No. 426), Orphan Drug Designation +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified per MOZ Order No. 460 (closely aligned with EU Regulation 1234/2008) into Type IA / IAIN (notification), Type IB (tell-wait-do), Type II (prior approval), and Extensions of registration.	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	Initial registration certificate valid for 5 years; subsequent renewal grants indefinite validity (mirroring EU framework), subject to favourable benefit/risk and submission of renewal documentation.	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	SEC's Department of Post-Authorisation Surveillance coordinates national pharmacovigilance through the AISF (Automated Information System for Pharmacovigilance) electronic system. Ukraine is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2002). MAHs must submit PSURs 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. EU GVP modules are progressively implemented.	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	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–90 days	30–60 days
GCP standard	ICH E6(R2) GCP (national MOZ Order No. 690); progressive alignment with EU Clinical Trials Regulation 536/2014; 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	Yes	Yes
HTA body	SEC Department of Health Technology Assessment performs HTA for inclusion of medicines in the National Essential Medicines List (NEML) and the Affordable Medicines reimbursement programme. NSZU operationalises reimbursement decisions.	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

UkraineMOZ / SEC
United KingdomMHRA

English submissions

UkraineYes
United KingdomYes

CTD accepted

UkraineYes
United KingdomYes

eCTD accepted

UkraineYes
United KingdomYes

Reliance pathway

UkraineAvailable
United KingdomAvailable

Reference agencies

UkraineFDA (US), EMA, MHRA (UK), Health Canada +4
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — National Procedure (Standard) · International Recognition Procedure (IRP)

Pathway name

UkraineNational Procedure (Standard)
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Ukraine210–365 days
United Kingdom60–110 days

Application fee

UkraineUAH 100,000
United KingdomGBP 35,305

Annual renewal

UkraineUAH 0
United KingdomGBP 0

Local representative

UkraineRequired
United KingdomNot required

Local manufacturing

UkraineNot required
United KingdomNot required

GMP inspection

UkraineRequired
United KingdomNot required

MAH & local presence

Local entity required

UkraineYes
United KingdomYes

Local responsible person

UkraineYes
United KingdomYes

RP role

UkraineEach MA holder must designate a Qualified Person for Pharmacovigilance (Upovnovazhena Osoba z Farmakonahliadu) — Ukraine-resident, registered with SEC, accountable for ADR reporting via the SEC AISF (Automated Information System for Pharmacovigilance) electronic system. PSURs aligned to ICH E2C(R2) submitted to SEC per the EURD-equivalent national list.
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

Ukraine4 designations
United Kingdom4 designations

Examples

UkraineWartime Simplified Procedure (Resolution 376, 2022), Abridged Procedure (Order No. 426), Orphan Drug Designation +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

UkraineVariations classified per MOZ Order No. 460 (closely aligned with EU Regulation 1234/2008) into Type IA / IAIN (notification), Type IB (tell-wait-do), Type II (prior approval), and Extensions of registration.
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

UkraineInitial registration certificate valid for 5 years; subsequent renewal grants indefinite validity (mirroring EU framework), subject to favourable benefit/risk and submission of renewal documentation.
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

UkraineSEC's Department of Post-Authorisation Surveillance coordinates national pharmacovigilance through the AISF (Automated Information System for Pharmacovigilance) electronic system. Ukraine is a member of the WHO Programme for International Drug Monitoring (Uppsala Monitoring Centre, since 2002). MAHs must submit PSURs 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. EU GVP modules are progressively implemented.
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

UkraineAvailable
United KingdomAvailable

Compassionate Use

UkraineAvailable
United KingdomAvailable

Emergency Import

UkraineAvailable
United KingdomAvailable

Parallel Import

UkraineNot permitted
United KingdomPermitted

Clinical trials

CTA approval

UkraineRequired
United KingdomRequired

Ethics approval

UkraineYes
United KingdomYes

CTA timeline

Ukraine60–90 days
United Kingdom30–60 days

GCP standard

UkraineICH E6(R2) GCP (national MOZ Order No. 690); progressive alignment with EU Clinical Trials Regulation 536/2014; Helsinki Declaration
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

UkraineRegulated
United KingdomRegulated

Reference pricing

UkraineYes
United KingdomNo

HTA required

UkraineYes
United KingdomYes

HTA body

UkraineSEC Department of Health Technology Assessment performs HTA for inclusion of medicines in the National Essential Medicines List (NEML) and the Affordable Medicines reimbursement programme. NSZU operationalises reimbursement decisions.
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)