The issues of legislative regulation and simplification of drug registration procedures were discussed by participants of the roundtable held on April 9 in the Russian State Duma.
“Due to the imperfection of statutory regulation for the procedure of state registration of drugs developed by domestic pharmaceutical manufacturers, there are serious issues in the classification of individual innovative drugs, the process of their introduction into circulation takes a fairly long time, and the state as a whole incurs severe economic losses,” stated the draft recommendations.
In particular, in the absence of effective system of scientific advice, Russian pharmaceutical companies are deprived of the opportunity to discuss with professional experts the issues arising during the state registration, which leads to displacement of domestic innovative products from Russian pharmaceutical market. In addition, the domestic pharmaceutical manufacturers conduct comparative studies of Russian innovative medicinal products with modern analogs, including the imported ones. However, due to uncertainty of the legal status, they experience serious restrictions when it comes to introducing them both in the standards of specialized medical and health care and in clinical recommendations, which results in the inability of domestic innovative drugs to compete with foreign medicines on equal terms.
In this regard, it is proposed to consider the possibility of preparing the regulatory acts on accelerated registration and clinical trials of domestic innovative drugs that demonstrate high efficacy and introducing special standards on preclinical studies and clinical trials for such drugs.