The Verkhovna Rada adopted on second reading and in General bill No. 4074 on access to the results of preclinical studies and clinical trials of drugs. Voted 247 deputies.
Online broadcast of the plenary sessions of Parliament led by the TV channel “112 Ukraine”.
Under the bill, the Ministry of health is obliged to publish on its website the results of preclinical studies and reports on clinical trials composed by a specially prepared form.
This will not publish information that contains commercial secret.
According to the explanatory note to the document, it is intended to harmonize domestic legislation regulating clinical trials of medicines, with the legislation of the member countries of the EU.
It is noted that this decision will enable all stakeholders to make decisions about the selection for appointment and medical use of medicines on the basis of objective data about the level of bringing their safety and efficacy. In addition, the bill aimed at overcoming corruption in the admission of medicines for medical use in Ukraine.
Recall, the Verkhovna Rada endorsed this document as a basis in the fall of 2016.