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”:
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.