A pharmaceutical forum of the EAEU and the CIS countries started on February 2. Representatives of Russian and CIS countries discussed issues of the formation and development of the single EAEU market.
Represenatavies of the national expertise centers of Armenia, Kazakhstan, and Kyrgyzstan discussed the process of drug registration and clinical trials as well as issues related to the fight against counterfeiting and smuggling of drugs and the creation of conditions that would prevent those drugs from entering the market of the Union. Creation of a single database of various violations would be the first step in the fight against counterfeiting. At the session, a design of the single EAEU pharmacopeia was debated. “The state pharmacopeia of Kazakhstan is harmonized with the requirements of the European, U.S. and U.K. systems. It is believed that the system of the Union has to be designed with respect to international requirements, Its structure and content should match the one of the European pharmacopeia,” said deputy director of the National Center of Drug Expertise of Kazakstan, Akmaral Kabdenov.
ARPM Director General, Victor Dmitriev was the moderator of the discussion on the confirmation of compliance with the GMP standards, certification, and mutual recognition. He spoke about the report made by State Institute of Drugs and Good Practices which is performing inspections in Russia. “There are 42 qualified inspectorates in Russia who are capable of performing the evaluation of foreign productions. 630 applications have been submitted to the Ministry of Industry and Trade in 2016 and 465 were submitted to the State Institute of Drugs and Good Practices. Expert evaluations have been conducted in 188 productions facilities in 40 countries. As a result, 163 reported were issued, 88 GMP certificates and 38 were denied the certificate,” said Mr. Dmitirev.
Each inspector had a special training. However, in the begging, the system experienced high rotation of staff. 15-20% of the first lineup remained until the end. It is impossible for 42 specialists to evaluate the forecasted number of facilities in Russia and overseas even in 12 months.
Another issue that was raised by Mr. Dmitirev was the problem with importing of pharmaceutical substances in Russia. “If a company is buying a substance from abroad, as registers it as finished medicines (with respect to the current regulation) then it is almost impossible to pass the customs because the Customs officials do not have it registered as an active pharmaceutical substance. Therefore, we have to appeal to different agencies to have an agreement on this issue.”
Participants of the conference were raising a question whether a Russian company could register a medicine in Russia based on the GMP certificate issued by Belarus? “According to the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, №93 «On recognition of the results of the inspection of drug products”, the answer is yes. However, it only works for pharmaceutical producers within the Union and not importers,” said Dmitry Rozhdestvensky, Head of coordination of work in the field of pharmaceuticals and medical products of the Technical Regulation and Accreditation Department.