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The Russian and the Chinese GMP inspectorates discussed the prospects for cooperation

In Beijing, a meeting between the Russian state GMP inspectorate and the Chinese regulator CFDI (Center for Food and Drug Inspection) was held. As a follow-up to the meeting, the inspectorate has started drafting the memorandum on cooperation between the two countries in the field of inspections and securing the safety of drugs.

In Beijing, a meeting was held between the Deputy Director of the Department of Pharmaceutical and Medical Industry Development of Minpromtorg of Russia Ms. Elena Denisova and the Chinese agency authorized for carrying-out GMP inspections abroad – CFDI (Center for Food and Drug Inspection). The interest towards mutual understanding between the Russian and the Chinese regulators is driven by the active bilateral cooperation in the pharmaceutical field.

As an outcome of the meeting, representatives of the regulators of the two countries outlined that they were starting preparing for drafting the memorandum on cooperation. Besides, the plan is to participate in the inspections carried-out as observers with the aim to secure transparency and build trust between the inspectorates. In its turn, the Russian party invited CFDI to join the council of GMP inspectorates of BRICS countries.

The State Institute of Drugs and Good Practices represents the regulating agency from the Russian side. From 2016, the staff of SID & GP have carried out 26 inspections of the manufacturing sites located within the PRC’s territory. As a result of the 14 out of them, a GMP compliance statement has been issued; 12 Chinese manufacturers haven’t managed to confirm their compliance with Good Manufacturing Practice standards. As reported by the Department of Pharmaceutical and Medical Industry Development of Minpromtorg of Russia, 6 more applications for carrying-out a GMP inspection from Chinese drug manufacturers have been filed to SID & GP, and the inspections are planned for 2019.

As a reminder, the Chinese products marketed within the Russian Federation territory today include medicines and food supplements. In 2018, the share of pharmaceutical products (medicines and food supplements) imported from China in the total volume of drugs market in the Russian Federation was 0.07% in monetary terms (or USD 15,014,533  out of USD 21,207,588,034.12) with 0.04% (or USD 8,296,523.05) in this figure being the share of medicines. In volume terms, the total amount of medicines and food supplements imported from China in 2018 was 1.4 mln packs with medicines only comprising the volume of 700,000 packs.

The Russian pharmaceutical market is mainly supplied from China by generics; in 2016 – 2018, in Russia, 29 INNs (30 tradenames) of Chinese drugs were being sold. Two INNs out of them were original drugs (Bicyclol and Wantong Artiplas), the volume of which in 2018 comprised 21.0 th. packs.

At the same time, Russian companies also show their interest in exporting their drugs to China. For instance, CJSC Biocad and Shanghai Pharmaceuticals Holding Co. Ltd. are planning to establish a joint enterprise in Shanghai. The objective of such partnership is clinical development, approval and launching to the Chinese market of at least 5 drugs based on monoclonal antibodies, including original drugs by CJSC Biocad used in present-day therapy of oncology and severe autoimmune diseases. It is planned to assign limited rights for commercialization of the following INNs within the PRC’s territory: bevacizumab, trastuzumab, adalimumab, infliximab, netakimab, prolgolimab.​ Such an approach will provide for enhancement of the export potential of the Russian pharmaceutical industry and will allow for implementation of the of bioproducts manufacturing technology transfer to the Chinese side in the shortest time possible, as well as set a new vector for promoting the cooperation between the two countries. This project is the first one within the framework of Russia-China cooperation in the pharmaceutical industry.

With the view to develop import and export between China and Russia, a meeting of the Russian delegation with the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPI) was organized. There, Minpromtorg of Russia and SID & GP answered the questions from Chinese pharmaceutical companies about the peculiarities of hosting Russian GMP inspections, including the timeframes and the procedure for carrying-out inspections at foreign manufacturing sites. As a result of the meeting, agreement was reached in terms of creating a mechanism of information exchange between NMPA, CCCMHPI, Minpromtorg of Russia and SID & GP on such topics as discontinuation and transfer of manufacture of APIs, including those supplied to Russia.