Health Care

02/ 08/ 2012

On 20 July 2012, the Ministry of Justice of Ukraine registered the Order of the Ministry of Health of Ukraine “On Amendments to the Order of Ministry of Health of Ukraine No 690 dated 23 September 2009 On Procedure of Clinical Trials’ Conduction and Expertize of Clinical Trials’ Materials” No 523 dated 12 July 2012. The Order will come into force after its official publication.

Background: On 17 May 2012 the Ministry of Health of Ukraine published for public discussion the Draft Order “On Amendments to the Order of Ministry of Health of Ukraine No 690 dated 23 September 2009 on Procedure of Clinical Trials’ Conduction and Expertize of Clinical Trials’ Materials”.

EBA HCC Clinical Trials Subcommittee had a number of meetings with Anatolii Morozov, Deputy General Director of State Expert Centre and Valentina Nikolayeva, Director of Clinical and Preclinical Trials Department of State Expert Centre and some agreements were achieved. Then it was prepared and sent the letter to the Ministry of Health of Ukraine and State Expert Centre with its proposals to the Draft Order.

The main points EBA advocated for, which were included into the text of the Order, are the following:

  1. Parallel submission of clinical trials’ materials to the State Expert Centre and Local Ethics Commissions.
  2. To remove a provision regarding liability insurance of investigators.
  3. Principal investigator submits SUSARs to Local Ethics Commissions and Sponsor (Applicant) to the State Expert Centre.
  4. To add the terms “Subject Identification Code” and “Substantial Amendment to the Protocol” to the Order.
  5. To mark the investigated product according to the annex 13 of Good Manufacturing Practice.

We are happy to share this success with our members who have been waiting for harmonisation of the procedure of clinical trials’ conduction in Ukraine.

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