On the 16th of February a draft legislation of Regulation № 4074 “On Amendments Concerning the Law of Ukraine “On Medicinal Products” (concerning the access to materials on pre clinical studies and clinical trials)(hereinafter- draft legislation) was registered in the Verkhovna Rada.
The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product. Relevant amendments have been foreseen to article 9 of the special Law.
In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness.
As of today, the draft legislation has been submitted to the Ministers of Parliament for review.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
