“The functioning of the unified market for medicines of the Eurasian Economic Union” is the topic of a round table that will be held on April 7 as part of the XII scientific-practical conference “State regulation and the pharmaceutical industry”. The main issues of law enforcement requiring priority attention will be discussed by representatives of the EEC and authorized bodies of the countries of the Eurasian Economic Union with leading experts in the pharmaceutical industry.
Since January 2021, pharmaceutical manufacturers will have to register their products only according to union requirements. And by 2025, the rules for the production and sale of pharmaceuticals and medical devices should be completely unified in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan. However, to implement the plan, a number of important tasks need to be solved.
Since 2017, the general rules for the circulation of drugs began to operate. In 2018, the information base of the pharmaceutical market of the Union was created. In 2019, the re-registration of drugs according to uniform rules began in the EAEU. The next step will be the introduction of a unified labeling of drugs.
According to the Deputy Director of the Department for the Technical Regulation and Accreditation of the EEC (Eurasian Economic Commission), Dzhanyl Dzhusupova: “the Eurasian Economic Commission has done tremendous work. It is based on three systems that ensure the uninterrupted functioning of the unified market and the access of medicines to it. This is a system of regulatory documentation, which includes 47 regulations, and a unified codification system, consisting of 34 directories and classifiers for medicines and medical devices, fully integrated into the international system for monitoring the safety of medicines, and a single information system from the register of medicines and related information databases, which allows transparent cross-border review of registration dossiers for medicines and is the basis for mutual recognition of the results of research on quality, safety and drug efficacy. "
According to the rules of the EAEU, 26 drugs have already been registered. Applications — more than 160. The first application and registration was carried out by Kazakhstan. Today the Russian Federation is leading. Registration is very intensive, but there are also cases of refusal to register. Dmitry Rozhdestvensky, Head of the Coordination Unit for Drugs and Medical Products at the Department for Technical Regulation and Accreditation of the Eurasian Economic Commission, said at one of the relevant conferences that “the main reasons for the rejection of the dossier are that the dossier is not set up in accordance with the classification of the Directory of dossier documents approved by the Eurasian Economic commission, in the form of electronic codes, which must contain each document that is part of the dossier. "
The round table participants will consider the advantages of the unified market and its impact on the development of related fields — logistics systems, artificial intelligence systems and IT technologies. But it is obvious that all these processes will lead to an increase in the life quality of patients.
We invite to take part in the XII Scientific and Practical Conference “State Regulation and Russian Pharmaceutical Industry: the continuation of the Dialogue”, which will be held on April 7 at the World Trade Center (WTC) in Moscow. Registration on the site www.arfp.ru is required!
AKRIKHIN is one of the leading Russian pharmaceutical companies, producing effective, affordable and high-quality medicines of the most popular by therapeutic groups of Russian patients. The company is among the five leading local pharmaceutical manufacturers in the Russian market in terms of sales.
Long Sheng Pharma — The company was founded in 1995 as a structural unit of the China State Holding Company for the production and sale of chemical-pharmaceutical equipment, pharmaceutical raw materials and petrochemical products. Today, Long Sheng Pharma has three international offices (Hong Kong, Beijing, Moscow), dozens of highly qualified employees, about 200 business partners in more than 40 countries. For 20 years in the pharmaceutical industry, the company has earned a reputation as a reliable business partner of the international level, a leading supplier to the CIS and Eastern Europe.
Pharmasynthesis is the largest producer of socially significant drugs in Russia. The company specializes in the development and production of anti-tuberculosis, anti-tumor, antiretroviral, hypoglycemic and hormonal drugs, antibiotics. The company’s portfolio of products includes more than 145 types of drugs. Since 2016, Pharmasintez has been one of the three fastest growing Russian pharmaceutical companies.
The general informational and analytical partner of the conference is Pharmaceutical Bulletin.
The Association of Russian Pharmaceutical Manufacturers (ARPM) brings together leading Russian pharmaceutical companies, which account for more than 90% of drugs produced in the country, about 45% of exports, more than 75% of drugs in the Provision of Essential Medicines (PEM) program. The activities of the Association are aimed at promotion of the competitiveness of the domestic pharmaceutical industry and facilitation of the integration of the domestic pharmaceutical industry into the world market while maintaining and increasing the production and financial potential of the industry. ARPM is a member of the Chamber of Commerce and Industry of the Russian Federation, actively cooperates with relevant federal state authorities: the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the State Duma Committee for Health Protection, Federal Service for Surveillance in Healthcare (Roszdravnadzor). Representatives of the ARPM are members of the Council for the Development of the Pharmaceutical and Medical Industry under the Government of the Russian Federation.