Ukrainian clinical trials regulatory framework

There is a legal framework regulated conduction of clinical trials in Ukraine that is providing compliance with GCP principles and ensuring safety of trial subjects. Key legislation that regulated the industry are:

  • Law of Ukraine “Principles of Ukrainian Health Care Legislation” No. 2801-XII of November 19, 1992 with amendments; Articles 3, 44
  • Law of Ukraine “On Medicines” No. 123/96-BP of April 04, 1996 with amendments; Articles 7, 8
  • Law of Ukraine “On Protection of Personal Data” No. 2297-VI of June 01, 2010 with amendments
  • Order of the Ministry of Health of Ukraine “Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees” No. 690 of September 23, 2009 with amendments (hereinafter – the Procedure)

Ukrainian legislation considered:

  • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for
  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
  • Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use
  • Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
  • ICH GCP
  • International ethical principles for biomedical research involving human subjects
  • Ethical Code of Doctor

Procedure for conducting clinical trials of medicinal products

This Procedure set basic requirements to conduction of:

  1. all types of clinical trials involving human subjects
  2. bioavailability and/or bioequivalence studies
  3. multicenter trials

This procedure shall not cover conduction of:

  1. non-interventional studies
  2. clinical trials within research activity without participation of pharmaceutical companies
  3. clinical trials of tissue and cell transplants, including stem cells of cord blood

Ukrainian Regulatory Authority is “The State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the Center) which is responsible for:

  • expert evaluation of materials of clinical trials
  • clinical audit (regulatory inspection in terms of ICH GCP) of the clinical trial of medicinal products

Table of content of the Procedure

The Procedure consist of 14 sections, 16 annexes and model regulation on composition and operation of otherwise independent Ethics Committees.

  1. General provisions
  2. Definition of terms
  3. General principles of conduction of clinical trials
  4. Primary requirements to protection of trial subjects
  5. Requirements to investigators and HCS/clinical trial site
  6. Primary requirements to labeling of investigational medicinal product
  7. Expert evaluation of materials pertinent to clinical trial of medicinal product
  8. Assessment of ethical, moral and legal aspects of clinical trial
  9. Conducting of clinical trial
  10. Changes and additions during conduction of clinical trial
  11. Completion of clinical trial
  12. Notification of adverse events and reactions
  13. Clinical audit of clinical trial of medicinal products
  14. Suspension or termination of a clinical trial

External links

This document is based on translation of the Procedure published at web site of State Expert Center.