Amendments to the regulation on clinical trials conducting in Ukraine

Oleksiy Bezhevets, Partner with Legal Alliance Company

New wording of the Order #523 “On Amendments to the Ministry of Health Order #690 dated September 23rd, 2009”, which amends the regulation on clinical trials conducting in Ukraine, came into force on August 6th, 2012.

Among the main novelties in clinical trials are the following:

• Transfer of ethics approval/supervision functions from the Central Ethics Committee to LECs. The updated regulation prohibits conducting clinical trials on a site where LEC is not established.The list of documents to be submitted for LECs review became shorter: no detailed information on investigational products, as well as no liability insurance contract and related documents have to be filed any longer. However, these documents are obligatory for submission to the State Expert Center. The positive change is that the Amendments eliminated duplication of the mentioned documents review by both ethics and regulatory authorities.
• New requirements to contractual framework between study participants. The Order allows sponsors (CROs) to establish contractual relations with both medical institution and investigational team members (first of all with investigators).
• Study subjects personal data protection. The Informed Consent shall include the study subject’s (his/her legal representative) consent to personal data processing according to the Law of Ukraine “On Personal Data Protection”.
• GMP Confirmation regarding Manufacturer of Investigational Medicinal Products. The Order extends the list of documents confirming GMP compliance of investigational products manufacturers: Ukrainian GMP certificate issued by the local GMP inspectorate (based on either inspection or documental confirmation for PIC/S countries) may be filed to prove the GMP compliance.
• Filing additional information about co(sub)-investigators. While filing application and related documents for approval of a study, CVs of co(sub)-Investigators (in addition to investigators CVs) shall be submitted whenever involvement of healthcare professionals with different specialization is required for the purpose of the study.