Since May 6, 2017 the main regulatory acts of the EAEU will be effective to ensure the operation of the common markets for drugs and medical devices in the Union, said Valery Koreshkov, the Member of the Board (Minister) of the Eurasian Economic Commission. The regulatory documents include 28 decisions of the EEC Council that adopted the registration rules, good practices (GxP), requirements for instructions and labeling, rules for conducting the trials of biological medicinal products, and a number of other acts.
The next two to three years will see the transition to the quality control of medicinal products in accordance with the Pharmacopoeia of the Union.
Valery Koreshkov commented on the key issues of introducing the so-called “conditional registration” procedure. This is a registration procedure establishing the post-registration measures, the non-compliance with which leads to cancellation of the marketing authorization. Such conditions include the requirements for incorporating certain measures into the risk management system in order to ensure the safe use of the drug, post-registration studies of the drug safety, additional requirements for registration and reporting of suspected adverse reactions, and several other measures. The established conditions and deadlines for their implementation are specified in the marketing authorization, unified register of drugs, and the instruction for use of the medicinal product. This procedure is implemented so that the patients can quickly get access to innovative drugs that are being launched for the first time to the markets of EAEU member states.