News of the EAEU

The Board of the Eurasian economic Commission approved The "guidelines for preclinical safety studies for clinical trials and registration of medicines".

The guidelines establish common approaches to the selection of the type and duration of preclinical safety studies as a justification for the possibility of future safe conduct of human clinical trials.

The document also eliminates differences in the scope of requirements for registration of medicines in the member States of the Eurasian economic Union, including the formation of a registration dossier for a new drug and its assessment in terms of proof of safety and benefit-risk ratio.

The adoption of the guidelines will eliminate the need to re-conduct preclinical studies in the EAEU member States when making changes to the registration dossier.

The Ministry of health of the Russian Federation issued the first registration certificate prepared in accordance with the decision of the Council of the Eurasian economic Commission dated November 3, 2016 No. 78 "on the Rules of registration and examination of medicines for medical use". The registration certificate was issued for Granisetron, a concentrate for the preparation of infusion solution, 1 mg / ml (produced by Ozon) on the basis of the procedure for bringing the registration dossier into compliance with the requirements of the EAEU.

According to the EEC Decision No. 78, registered drugs must undergo the procedure of compliance with the rules of the single market and all dossiers must be brought into compliance with the requirements of the EAEU by December 31, 2025. To date, the Ministry of health of the Russian Federation has 7 applications for new registration and almost 40-for bringing into compliance with the rules of the EAEU. Given the volume and timing of expert work, the Ministry of health asks to speed up the submission of applications for bringing the dossier into line.

Currently, the Unified register of registered medicines of the Eurasian economic Union contains 6 names of drugs registered by regulatory authorities of the Republic of Kazakhstan.

At the November meeting of the Committee on legal support of business of the EAEU, the issues of parallel import were discussed.

The current Russian legislation prohibits entrepreneurs to apply parallel import and import into the territory of the Russian Federation goods for resale without the permission of the copyright holder. Such goods will be recognized as counterfeit, confiscated by the customs service, and the entrepreneur will be punished. However, often the right holder abuses his exclusive right: sets monopolistically high prices for original products, as well as preventing its import and release into the country.

Legalization of parallel imports would allow to solve, first of all, such a problem as price, quality and assortment discrimination on the part of rights holders against Russian consumers. In addition, this measure may be protective in case of possible restrictions on the supply of goods to the country as a result of "sanctions". Also, with the permission of parallel imports, we can talk about lifting restrictions on the activities of small and medium-sized businesses, in particular, the possibility of creating additional jobs.

However, the Antimonopoly Agency also highlights a number of shortcomings that this initiative brings with it:

  • threat to foreign investment in the economies of the EEC member States;
  • the possibility of increasing the volume of counterfeit goods;
  • limitation of warranty and service for the consumer.

As a mechanism of protection against counterfeit products, the FAS of Russia proposes to create a special customs post for the clearance of goods of parallel importers. At the same time, this innovation will not affect traditional importers, for whom the import procedure will remain unchanged.

Another important mechanism to protect against the consequences of the introduction of parallel imports FAS Russia considers the localization of production. This measure will protect the interests of companies that have already placed their production in Russia.

The Association of pharmaceutical manufacturers of the Eurasian economic Union with the support of the Ministry of industry and trade of Russia and the Eurasian economic Commission held a specialized conference on the development of the pharmaceutical market of the Union.

The main topic of discussion was the unity not only the proper rules of production of medicines (GMP rules) and the procedure of inspection in terms of deadlines for separate stages of inspection (which is now relegated to the legislations of the member States of the Union), by creating a bodies, expert committees and the Inspectorate.

Currently, within the framework of bringing national regulations to supranational rules of the EAEU, there is a difference in approaches and methods of assessing manufacturers for compliance with GMP requirements. For example: the cost of inspection in the member States of the Union, the regulatory terms of the inspection, the requirements for qualification and certification of inspectors, the lack of experience in specific types of drugs), as well as the resources of countries (the Inspectorate of the Russian Federation has 90 inspectors, for three years, about 1000 inspections of Russian and 1800 inspections of foreign manufacturers).

According to the site http://www.eurasiancommission.org

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