Prospects of Cooperation between Russian and Korean Regulators

| By | Korean Pharma, Russian Pharma
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On June 26-28, «Bio Innovation, New-Found Future» Global BIO Conference (GBC) 2019 took place in Seoul (Republic of Korea), in the framework of which the working sessions were held with senior representatives of the Ministry of Food and Drug Safety of the Republic of Korea, representatives of the Korea Health Industry Development Institute and pharmaceutical companies.

The Minpromtorg of Russia (the Deputy Director of the Pharmaceutical and Medical Industry Development Department of the Minpromtorg of Russia Elena Denisova and the Head of the Training and Development Department of the Inspectorate of the FSI «SID & GP» under Minpromtorg of Russia Ivan Gulyaev) hold a series of working meetings with the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) and Korean pharmaceutical manufacturers in the framework of the Conference «Bio Innovation, New-Found Future». During the event, the parties spoke about the current regulatory system in the countries in the field of quality control and compliance with medicines standards, and also discussed prospects for further cooperation.

The current legislative basis of the regulatory system was formulated in 2004 in the Medical Device Act (MDA), which is in force today as amended in 2017. The Food and Drug Administration (KFDA), which was established in 1998, has become the basis for the current Ministry of Food and Drug Safety (MFDS). This Ministry has three departments responsible for medicines issues:

  • Pharmaceutical Safety Bureau (FSB);
  • Biopharmaceuticals and Herbal Medicines Bureau (BHMB);
  • Medical Device Safety Bureau (MDSB).

MFDS is a member of WHO, PIC/S, has been a member of ICH since 2016, is also a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), and is a regular participant of the International Conference of Drug Regulatory Authorities (ICDRA).

According to statistics, during recent years, the South Korean pharmaceutical market has been recognized as the third largest in Asia.

According to the State Register of Medicines (hereinafter – GRLS), as of May 2019, 13 medicines from Korea had been registered in the Russian Federation (12 medicines are not localized in the Russian Federation, 1 medicine with the trade name Flammegis [INN Infliximab], owner RU: Celltrion Healthcare Co. Ltd [Korea] is being produced from the packaging stage at the production facilities of the company «Nanolek LLC»). According to the data of the statistical reporting form 2lek (prom), in 2018 a typhoid vaccine with the trade name Vianvac (typhoid vaccine) was exported from Russia to Korea in the amount of 12.22 million rubles in value terms or 200,004 units in physical terms (in-bulk). There is also export of medical products from Russia to Korea. Based on the reporting data according form 1-mediz, the total export volume of medical products to Korea in 2018 reached 355.51 thousand rubles in value terms. These were the products of NPP «Technomedica», «Titan Surgical» and «Elamed». For the first quarter of 2019, the total export of medical products to Korea was 264,78 thousand rubles. Products had been exported by «Elamed» and «Triton Electronics».

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