10.Aug.2012

Recent Regulatory Changes in Ukraine – New Study Application Procedure

Since June 2012, there have been some major changes integrated into Ukraine’s regulatory approval requirements. The new act went into effect in July 2012 to substitute act #690 dd. 23 September, 2009 regulating the process of clinical trials conduct in Ukraine.

Since June 2012, there have been some major changes integrated into Ukraine’s regulatory approval requirements. The new act went into effect in July 2012 to substitute act #690 dd. 23 September, 2009 regulating the process of clinical trials conduct in Ukraine.

Before July 2012, to begin a study in Ukraine, approvals of the State Expert Centre and Central Ethics Committee of Ukraine were required. Local Ethics Committees affiliated with study sites needed to be notified only of the new trial launched. Ukrainian Ministry of Health would review the State Expert Centre decision and issue an approval letter. Previously Ukrainian LECs (each study site has its own local ethics committee) needed to be notified about a new trial launch at a site, and no approval letter had to be issued by LEC.

The new act #523 dd. 12 July 2012 introduces several changes to The Law of Ukraine “On Pharmaceutical Products”:

  1. Central Ethics Committee has been abolished.
  2. Ethics aspects of clinical trials conduct in Ukraine will be considered by the Local Ethics Committees (LECs) affiliated with clinical sites:
    • Clinical trials application can be performed simultaneously to the State Expert Centre and LECs;
    • Initial LEC approval procedure will take up to 30 days to be issued, amendments – 10 days;
    • Power of attorney gives a CRO company the right to do a LEC application on behalf of Sponsor;
    • LEC approval is free of charge.
  3. The list of Documents submitted to the State Expert Center remained unchanged. The only change implemented here touched on the application letter form.
  4. The new law also describes new clinical trial contract requirements.

New Regulatory Approval Process in Ukraine

New Regulatory Approval Process in Ukraine

Some changes have been made to the medical devices state registration process:
According to the new act # 548 On the Amendments in the Medical Devices State Registration Procedure issued on June 20, 2012 (as an amendment to the existing one # 1497 On the Order of State Regulation of Medical Devices as of September 9, 2004), the validity period of the registration certificate of a medical device is not limited any more. Previously, the applicant company had to renew the registration (re-registration) sequentially every 5 years.