CMU's new draft regulation prescribes public access to information on the quality, efficacy and safety of medicines

On August 27th, 2019, the Ministry of Health of Ukraine promulgated a draft resolution of the CMU "On Amendments to Clause 4 of the Regulation on the State Register of Medicines" (hereinafter – “the draft resolution”), designed to introduce a system of public access to information on the quality, efficacy and safety of medicinal products allowed to the Ukrainian market.

To date, the Ministry of Health maintains the State Register of Medicines (hereinafter referred to as “the Register”), which contains information on all medicines authorized for production and use in medical practice in Ukraine. Data about the medicinal product to be entered on the Register is provided by clause 4 of the Regulation on the State Register of Medicines, approved by CMU Resolution of March 31, 2004 No. 411 (hereinafter – “the Regulation”).

It should be reminded that Article 9 of the Law of Ukraine "On Medicines" and the State Strategy for the Implementation of the State Policy for Providing the Population with Medicines for the period up to 2025, approved by CMU Resolution No. 1022 of December 5th, 2018 (hereinafter – “the State Strategy”), laid the ground for implementation of the public access system to all preclinical study and clinical trial results.

The State Strategy orders the Ministry of Health of Ukraine by 2023 to develop and implement a system of public access to information on the level of evidential therapeutic equivalence and efficacy of medicinal products that are allowed to the Ukrainian market.

In response, the draft regulation proposes to amend clause 4 of the Regulation by supplementing it with a provision on the need to enter on the Register data on the equivalence of a medicinal product according to the types of medicinal products to be approved by the Ministry of Health in the near future.