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Problems of drug market regulation: Russia and the EAEU

On all the issues considered, proposals were formulated aimed at using world experience, taking into account the state of affairs in the EAEU

Andrey Meshkovsky Associate Professor of the Department of Industrial Pharmacy, P.M. THEM. Sechenov

Ravil Niyazov Specialist in the development and registration of drugs, Scientific Consulting Center LLC

Margarita Dranitsyna Biostatistic Scientific Consulting Center LLC


This review focuses on the shortcomings of Russian practice in the field of pharmaceutical regulation. For all the positions touched upon, proposals were formulated aimed at using world experience, taking into account the state of affairs in the Eurasian Economic Union (EAEU).

Regulatory mechanism. Five federal-level structures are involved in the regulation of drug circulation: the Ministry of Health of Russia, the Ministry of Industry and Trade of Russia, Roszdravnadzor, FAS Russia and Rosakkreditatsiya, the first three together with their subordinate institutions. There is no integrated approach to sectoral regulation, the importance of which is highlighted by international organizations and leading national agencies.

Terminology. Many terms and definitions used in the sectoral regulatory system are not consistent with the concepts accepted in world practice. The term “medicinal / pharmaceutical product”, widely used in the world practice, is absent. Legal and regulatory documents of the industry often confuse or, conversely, unreasonably separate the concepts of “drug”, “drug”, “pharmaceutical product”, “finished product” and “final product”. The interpretation of the key concept of "drug quality" is outdated.

The volume of regulatory and methodological documents. The Federal Law "On the Circulation of Medicines" is about 140 pages, while the legislation of the EU member states in this area is about 700-800 pages, the US legislation is about 1000 pages.

Lack of consistency of requirements and rules with international regulations. In the Russian pharmaceutical industry, many important regulatory and methodological documents from among those recognized at the international level regarding pharmaceutical development and production process development, validation of production processes and analytical methods, quality specifications, regarding the assessment of bioequivalence / bioavailability, technology transfer, do not have an official status. preclinical and clinical development, etc.

Recognition of the results of the work of foreign regulators. In Russia, there is officially no practice of recording, using or recognizing foreign regulatory assessments and decisions. Abroad, the practice of accounting and use in various forms and degrees of regulatory assessments and decisions made / taken in other jurisdictions is expanding. This allows for more rational use of available resources by eliminating duplication of actions and focusing efforts on national problems, for example, the control of drug market operators.

Participation in international cooperation mechanisms. Domestic organizations and specialists have little contact with expert committees and working groups of the pharmaceutical profile of WHO, ICH, European Union, FIP. Meanwhile, in the WHO documents, the participation of regulators in the work of international cooperation mechanisms is considered as an important sign of the progressiveness of regulatory structures.

Compliance with GLP requirements. Russia is not a member of the OECD Mutual Data Recognition System. The Russian Good Laboratory Practice Rules are not GLP rules in the full sense of the word. Most of the domestic pharmacological and toxicological testing centers do not comply with internationally accepted GLP standards.

Organization of clinical trials. Domestic requirements GCP is an abbreviated version of the international standard ICH E6 (R2): not all participants in the clinical research process are inspected. This does not allow to fully protect the interests of participants in clinical trials and ensure the scientific purity of the data obtained.

In Russian legislation, there is an unreasonable requirement to conduct local pre-registration clinical trials of new drugs.

Unlike foreign regulatory systems, when obtaining a permit for a clinical trial, it is not required to describe the production and confirm the quality of the investigational medicinal product and the relationship between the developed product and the product being launched on the market.

Market admission. The procedure for the admission of medicinal products for sale is not transparent. There are two structures involved in the admission procedure; accordingly, the procedure itself is divided into two parts: "registration" carried out by the authorized body, and "examination" of the documents attached to the application for registration. The concepts of "registration" and "examination" have no definitions. The expert organization was entrusted with the examination. Separation details: specific actions and responsibilities of the involved structures are not defined.

The practice of drug expertise. In Russia, the processes of synthesis of an active substance within the framework of the examination of the registration dossier of a medicinal product are not evaluated, analyzed, and, as a consequence, the validity of the standardized levels of impurities is not assessed. The manufacturing process of a medicinal product is also not assessed in terms of quality risks.

Pre-registration laboratory analysis of samples. In domestic practice, there is an excessive emphasis on laboratory and instrumental control methods to the detriment of documentary expertise. During the pre-registration examination of a medicinal product in the pharmaceutical quality section, a lot of effort is spent on checking the so-called regulatory documentation - a document that does not exist abroad.

GMP rules. In Russia, the GMP rules are based on the EU GMP Guidelines, in the process of translation of which many mistakes were made. After the approval in 2013, the Russian GMP standards were not revised, and therefore their lag behind the European ones is growing. The current GMP Rules contain references to industrial regulations, a significant part of the sections of which are not related to product quality assurance. At the same time, there are no analogues of the new EU documents closely related to GMP rules.

Inspection for GMP compliance. This function is entrusted to the Ministry of Industry and Trade of Russia, while the central link of the sectoral regulatory system - the admission of drugs to the market (registration) - is controlled by the Ministry of Health of Russia. As a result, an important regulatory principle has been violated, according to which the registration of a medicinal product should be closely linked with the inspection of pharmaceutical production. In addition, in violation of the principles proposed by the WHO GRP project, a prerequisite for a conflict of interest has been created: production control (licensing and inspection for compliance with GMP requirements) is carried out by the agency responsible for the development of the pharmaceutical industry.

Importer licensing. There is no concept of “licensing of importers” in the Russian pharmaceutical sector. For the import of medicinal products, a license for wholesale trade in this type of goods and separate permits for the import of specific batches of medicinal products are sufficient. In other words, this section of pharmaceutical regulation is not related to GMP, which is inconsistent with global approaches.

Pharmacopoeia and regulatory documentation. The prescriptions of the State Pharmacopoeia (GF) are not consistent with the requirements of the leading pharmacopoeias; the system of pharmacopoeial requirements itself is not consistent with the requirements for the development, production and quality control of medicinal products and their components. In the domestic quality control system, the main control document is regulatory documentation (regulatory document) that does not exist abroad.

The final part of the review is devoted to the specifics of the regulation of some categories of drugs. It discusses the shortcomings of the current regulation of the circulation of orphan drugs and drugs intended for pediatrics.

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