Ministry of Healthcare of Ukraine approved the order, dated 12.18.2014 № 966, which amends the Order on procedure of clinical trials of medicinal products and expert assessment of material for clinical trials, approved by the Ministry of Healthcare, dated 23.09.2009 № 690. The document was entered into force 17.02.2015.
Today, the basis for clinical trials of medicinal products is a positive conclusion of the State Expert Centre approved by the Ministry of Healthcare in the form of backing. The changes in the legislation provide that the Ministry of Healthcare decision will be taken in the form of order and positive conclusion of the State Expert Centre.
The Order of the Ministry of Healthcare № 966 requires that the sponsor of clinical trials before the clinical trials should enter into a contract for insurance of life and health of the patient (healthy volunteers). However, this provision is not a novel, since such requirement has provided by the Law of Ukraine "On Medicinal products" and otherwise was still presented in Order of the Ministry of Healthcare № 690. The requirement to conclude such an agreement is not in compliance with international practice, which provides liability insurance of sponsor of clinical trials.
Unlike the current procedure, the application for clinical trials and cover letter will be submitted to the Ministry of Healthcare of Ukraine. Other documents will be sent directly to the State Expert Centre.
Currently, the confirmation about the compliance of the manufacturing of researched medicinal product with the requirements of GMP is submitted. According to the latest amendments, in the case, when documents confirming such compliance were added to the database EudraGMP, the applicant will be able to present a link to this database and self-certify copies of such documents.
The term of examination of the application for clinical trials is reduced from 50 days to 47 days; the term of decision-making after examination by the Ministry of Healthcare - 5 working days instead of 10 days; the term of examination of amendments reduced from 30 days to 27 days; the term of examination of application for review of a decision of the Ministry of Healthcare to refuse the clinical trial - 30 days instead of 60 days.
In addition, the Order of the Ministry of Healthcare approved the new form of the following documents:
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