Barshadskaya O S
INTRODUCTION. One of the socially significant directions in the development of pharmaceutical products is the provision of high-quality, effective and safe medicines intended for the treatment of orphan (rare) diseases among the population of the Member States of the Union. The availability of medicinal products for such patients suffering from such diseases should be regulated by state incentives for the development and launch of orphan drugs from do- mestic manufacturers through the updating and timely updating of regulatory legal acts in the field of marketing authorization (MA) of medicinal products, as well as providing benefits when initiating the registration process. AIM. To assess the prospects and possibilities of putting orphan drugs into circulation within the framework of the Eurasian Economic Union for domestic manufacturers. MATERIALS AND METHODS. The study materials were available publications in peer-reviewed journals on thematic queries based on keywords of the se- lected topic, official websites, regulatory legal acts, regulating the procedure for registering medicinal products in the Eurasian Economic Union and the Russian Federation. RESULTS AND DISCUSSION. A review of national legislation on MA and regulation of the circulation of orphan drugs revealed several critical problems that prevent domestic manu- facturers from introducing drugs of this group to the pharmaceutical market of the Eurasian Economic Union, such as lack of regulation of the list of orphan drugs and a simplified registration procedure in the custom territory of the Eurasian Economic Union, complexity procedures for assigning an orphan drug status, etc. Imperfections in the regulatory regulation of these issues predetermine problems in drug provision for patients with orphan diseases in the Eurasian Economic Union. Conclusion. A review of the problems and possibilities of putting orphan drugs into circulation by domestic manufacturers needs to improve legal regulation both at the level of the Russian Federation and within the legal framework of the Eurasian space.
INTRODUCTION. One of the socially significant directions in the development of pharmaceutical products is the provision of high-quality, effective and safe medicines intended for the treatment of orphan (rare) diseases among the population of the Member States of the Union. The availability of medicinal products for such patients suffering from such diseases should be regulated by state incentives for the development and launch of orphan drugs from do- mestic manufacturers through the updating and timely updating of regulatory legal acts in the field of marketing authorization (MA) of medicinal products, as well as providing benefits when initiating the registration process. AIM. To assess the prospects and possibilities of putting orphan drugs into circulation within the framework of the Eurasian Economic Union for domestic manufacturers. MATERIALS AND METHODS. The study materials were available publications in peer-reviewed journals on thematic queries based on keywords of the se- lected topic, official websites, regulatory legal acts, regulating the procedure for registering medicinal products in the Eurasian Economic Union and the Russian Federation. RESULTS AND DISCUSSION. A review of national legislation on MA and regulation of the circulation of orphan drugs revealed several critical problems that prevent domestic manu- facturers from introducing drugs of this group to the pharmaceutical market of the Eurasian Economic Union, such as lack of regulation of the list of orphan drugs and a simplified registration procedure in the custom territory of the Eurasian Economic Union, complexity procedures for assigning an orphan drug status, etc. Imperfections in the regulatory regulation of these issues predetermine problems in drug provision for patients with orphan diseases in the Eurasian Economic Union. Conclusion. A review of the problems and possibilities of putting orphan drugs into circulation by domestic manufacturers needs to improve legal regulation both at the level of the Russian Federation and within the legal framework of the Eurasian space.
