April 2019: Ukraine Regulatory Update

The Ministry of Health of Ukraine has prepared a mechanism for publicizing the results of clinical trials

The Ministry of Health of Ukraine has issued a draft order to publicize the results of preclinical studies and clinical trials, according to which each manufacturer will have to disclose evidence of the safety and efficacy of the drug. The results of the research reports will include all data, evaluations, results of a statistical analysis of the therapeutic effect of the drug and adverse reactions from the study.

Approximately, the research findings will be verified within 30 days. After receiving a positive opinion of the experts, the report on the results of the research will be published on the website of the Ministry of Health of Ukraine.

For already registered drugs, the Ministry envisioned a transitional period. Within 5 years from the date of entry into force of the Order, pharmaceutical manufacturers should prepare and send for examination reports on all clinical trials and preclinical studies of their drugs.

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