2020 was the year of bringing the drug dossier in correspondence with the unified rules of the EAEU, but the COVID-19 pandemic intervened in this process. In the union states, GMP inspection of sites has been temporarily suspended, and in Russia remote methods of checking good manufacturing practices are being introduced. These are not the only pitfalls on the way to a unified pharmaceutical market. The main issues of law enforcement that require priority attention will be discussed by representatives of the authorized bodies of the countries of the Eurasian Economic Union with leading experts of the pharmaceutical industry at the conference "State regulation and the Russian pharmaceutical industry: continuation of the dialogue" on October 27 online.
From January 2021, pharmaceutical manufacturers will have to register their products only in accordance with union requirements. And by 2025, the rules for the production and sale of pharmaceuticals and medical devices should be fully unified on the territory of Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. However, a number of the Union states have taken the initiative to keep the national drug registration systems in force in parallel with the Union’s norms and to postpone the transition period for two years.
“These proposals must have a serious justification with an indication of the work plan. But, I think that there was enough time for preparation, — emphasized Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers. — Maintaining a dual system is a big burden on both the regulator and the business. A tremendous amount of work has been done in Russia and by the end of the year all legislation will be brought into line with the Eurasian requirements within the framework of the “regulatory guillotine” mechanism. If we postpone the transition period, then we will have to return to maintaining the two systems, which is costly, irrationally and negatively affects the medical supply of the population of our countries. "
The single pharmaceutical market will reduce barriers associated with the specifics of national pharmaceutical markets, significantly increase the quality, safety and effectiveness of drugs, and most importantly, accessibility for the population of the participating countries.
To date, pharmaceutical companies in five countries are actively registering drugs under new rules, bringing the portfolio’s registration dossiers in correspondence with the established requirements. More than 80 drugs have already received registration certificates according to the rules of the EAEU. About 400 dossiers are under examination, of which 310 are in the Russian Federation. Registration is very intensive, technical problems arise with a single integrated information system. Its throughput is much lower than the volume of documents provided at present.
Registration procedures, issues of inspection and issuance of the EAEU GMP certificates of conformity, the results of the transition period and the prospects for a single union market are in the focus of industry experts. Within the framework of the conference, other equally important topics will be touched upon: the introduction of global drug provision, quality control in the field of drug circulation, issues of interchangeability, pricing, and labeling.
Registration is open on the website www.arfp.ru
Conference partners:
“AKRIKHIN” is one of the leading Russian pharmaceutical companies producing effective, affordable and high-quality medicines for the therapeutic groups most demanded by Russian patients. The company’s product portfolio includes about 200 drugs, more than 55% of which are sold are included in the VED list. The drugs belong to the main pharmacotherapeutic areas: pulmonology, endocrinology, dermatology, cardiology, neurology, gynecology, etc. and are produced in full compliance with GMP standards. Fully complying with the state and industry priorities, AKRIKHIN JSC actively participates in the localization and import substitution of medicines both by its own Research and Development Center and in partnership with international pharmaceutical manufacturers. The “AKRIKHIN” company employs 1,500 employees, of which more than 800 are at the production site in Staraya Kupavna, Moscow region.
PHARMASYNTEZ is a leading domestic manufacturer of medicines for the treatment of socially significant diseases such as tuberculosis, HIV, oncology, diabetes mellitus, and hepatitis. Production facilities are represented by five modern high-tech factories in the cities: Ussuriysk, Irkutsk, Bratsk, Tyumen, St. Petersburg. The company’s product portfolio includes over 170 types of drugs in various dosage forms: capsules, tablets, granules, infusion solutions, dry sterile powders and lyophilisates, as well as solutions for injections. More than 80% of manufactured drugs are included in the list of vital and essential drugs. The annual production volume exceeds 70 million packages. Revenue at the end of 2019 amounted to 22.7 billion rubles.
Long Sheng Pharma is a structural division of the Chinese State Holding for the production and trade of chemical and 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. Over 20 years in the pharmaceutical industry, Long Sheng Pharma has gained a reputation as a reliable international business partner, a leading supplier to the CIS and Eastern Europe.
General information partner — Pharmaceutical Bulletin
Media partners: Duma TV channel, Komsomolskaya Pravda publishing house, Regions of Russia media holding, Remedium.ru information and analytical portal, GMP News Media project, Moskovskiye Apteki (Moscow Pharmacies) newspaper for pharmacy specialists, social network for professionals of the pharmaceutical industry "Pharma RF", information and analytical journal "Pharmacy Union", the scientific journal "Development and registration of medicines", the journal "Pharmaceutical technologies and packaging", journal "Polyclinic".