§ 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	🇪🇺European Union
Authority & dossier
Regulatory authority	MOZ / SEC	EMA
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	—
Lead pathway (timeline & fees) — National Procedure (Standard) · Centralised Procedure
Pathway name	National Procedure (Standard)	Centralised Procedure
Approval timeline	210–365 days	210–277 days
Application fee	UAH 100,000	EUR 358,800
Annual renewal	UAH 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 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 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	4 designations	6 designations
Examples	Wartime Simplified Procedure (Resolution 376, 2022), Abridged Procedure (Order No. 426), Orphan Drug Designation +1	Accelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3
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.	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	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 — 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	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.	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	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–90 days	60–106 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) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	Yes
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.	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

UkraineMOZ / SEC
European UnionEMA

English submissions

UkraineYes
European UnionYes

CTD accepted

UkraineYes
European UnionYes

eCTD accepted

UkraineYes
European UnionYes

Reliance pathway

UkraineAvailable
European UnionAvailable

Reference agencies

UkraineFDA (US), EMA, MHRA (UK), Health Canada +4
European Union—

Lead pathway (timeline & fees) — National Procedure (Standard) · Centralised Procedure

Pathway name

UkraineNational Procedure (Standard)
European UnionCentralised Procedure

Approval timeline

Ukraine210–365 days
European Union210–277 days

Application fee

UkraineUAH 100,000
European UnionEUR 358,800

Annual renewal

UkraineUAH 0
European UnionEUR 122,500

Local representative

UkraineRequired
European UnionRequired

Local manufacturing

UkraineNot required
European UnionNot required

GMP inspection

UkraineRequired
European UnionRequired

MAH & local presence

Local entity required

UkraineYes
European UnionYes

Local responsible person

UkraineYes
European UnionYes

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.
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

Ukraine4 designations
European Union6 designations

Examples

UkraineWartime Simplified Procedure (Resolution 376, 2022), Abridged Procedure (Order No. 426), Orphan Drug Designation +1
European UnionAccelerated Assessment, Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +3

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.
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

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.
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

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.
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

UkraineAvailable
European UnionAvailable

Compassionate Use

UkraineAvailable
European UnionAvailable

Emergency Import

UkraineAvailable
European UnionAvailable

Parallel Import

UkraineNot permitted
European UnionPermitted

Clinical trials

CTA approval

UkraineRequired
European UnionRequired

Ethics approval

UkraineYes
European UnionYes

CTA timeline

Ukraine60–90 days
European Union60–106 days

GCP standard

UkraineICH E6(R2) GCP (national MOZ Order No. 690); progressive alignment with EU Clinical Trials Regulation 536/2014; Helsinki Declaration
European UnionICH E6(R3) — Commission Regulation (EU) 2024/2748 transposing R3, applicable from 23 July 2025

Pricing & reimbursement

Price regulation

UkraineRegulated
European UnionRegulated

Reference pricing

UkraineYes
European UnionYes

HTA required

UkraineYes
European UnionYes

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