Within the Eurasian Week in Erevan, the issues of harmonizing the drugs and medical devices regulations in the EAEU were discussed
On 24 October, the representative of the State Institute of Drugs and Good Practices took part in the expert session on the topic «The common market of drugs and medical devices: harmonization of regulations and mutual recognition», which was held within the International Forum «Eurasian Week» in Erevan. This Forum is the major business event aimed at development of cooperation relations as well as enhancement of the economic, investment, and export capacities of the EAEU.
The rules of drugs registration within the EAEU territory have been effective for more than a year. Still, launching of the common drugs circulation market is being restrained by the absence of the common informational system and the missing harmonized regulatory framework in the EAEU member countries. The expert session on the topic «The common market of drugs and medical devices: harmonization of regulations and mutual recognition» was attended by the representative of FSI «SID & GP» Mr. Vladimir Orlov, Area Manager of EAEU Pharmaceutical Inspectorates Cooperation Organization Department at FSI «SID & GP». Session participants discussed the most topical issues, such as establishment of the common market of drugs and medical devices in the EAEU, the barriers faced on the way of its establishment, the issues of harmonization and convergence of legal requirements in terms of drugs circulation in the EAEU member countries, and other problems encountered when switching to the common EAEU standards.
In his speech, Mr. Vladimir Orlov talked about the structure of the Institute and its main areas of activity. He also addressed the topic of regulatory environment towards drugs circulation and harmonization of legal requirements with the EAEU law.
«The agreement about the unified principles and rules of drugs circulation within the Eurasian Economic Union is the basic document according to which the EAEU member countries are implementing a coordinated policy in terms of drugs circulation» – explained Area Manager of EAEU Pharmaceutical Inspectorates Cooperation Organization Department at FSI «SID & GP» Mr. Vladimir Orlov. «In 2016, the Eurasian Economic Commission signed a package of documents on regulating the common market, but the activities on establishing an adequately-functioning common market of drugs have not yet been finalized and are still ongoing.»
The Federal State-funded Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia is implementing a number of initiatives towards cooperation of the EAEU pharmaceutical inspectorates. In April 2018, the first WHO Global Learning Opportunities GMP course was held for the Russian-speaking countries within the joint educational program for regulatory authorities of the EAEU member countries. Joint inspections with participation of regulatory agencies from Russia, Armenia, Kazakhstan, and Kirghizia are carried out. The All-Russia GMP Conference with International Participation is organized every year.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed