Discussion on prospects of cooperation between Russia and China in the field of biopharmaceutics was conducted at SID&GP
The Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation and the State Institute of Drugs and Good Practices (SID&GP) have conducted a working meeting with Chineese biopharmaceutical companies dedicated to cooperation in the context of pharmaceutics. As well as that, during the meeting a great attention was drawn to the specifics of GMP-inspections.
A meeting between Russian regulators and Chineese developers and manufacturers of recombinant proteins, human blood plasma medicines, veterinary vaccines and equipment suppliers for biopharmaceutical manufacturing was held yesterday evening at SID&GP. The main focus of the meeting was to seek for new cooperation opportunities in the field of biopharmaceuticals. The Russian side has acknowledged the represenattives of Chineese companies with Russian relevant legislation, structure of Russian inspectorate and Russian market’s course of development.
Special attention was paid to the issue of conducting inspections at foreign manufacturing sites. As for the Chinese manufacturers, according to the statistics, out of 32 GMP-inspections conducted by SID&GP for the period of 2016 – 1st half of 2019, only 17 Chinese manufacturers have received certificates on GMP standards compliance.
“Any inspection requires both the manufacturing site and the inspectorate preparation for it,” – noted Vladislav Shestakov, Director of the SID&GP.
During the meeting, representatives of Chinese companies asked about the differences between Russian and European legislation requirements in the field of GMP. The representatives of SID&GP have reminded that during the Russian GMP rules development the EU rules were taken as a basis. However, since the latest version of the GMP Rules of the Russian Federation release (Order No. 916 as amended by Order No. 4148 of the Ministry of Industry and Trade of the Russian Federation dated 18.12.2015), there have been a number of changes in the EU GMP rules, which were reflected in the new editions of the GMP sections. These changes concern personnel, premises and equipment, manufacture, quality control, reclamations and product recalls. In particular, the Personnel Chapter now details the responsibilities of senior management when governing the Pharmaceutical Quality System, and the description of key personnel includes a reference to the Head of the Department, etc. Also, SID&GP representatives have introduced to Chinese pharmaceutical manufacturers the current legislation in the field of GMP, which regulates the EAEU market.
The parties also discussed the prospects of cooperation in the field of engineering. The Engineering and Design Department at SID&GP is ready to assist Chinese companies in the project documentation implementation at the “Conceptual Project” stage of manufacturing sites (corpses, factories) in GMP-critical areas: technological, architectural and planning solutions, heating, ventilation and air conditioning as well as technical audits.
The meeting between the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, SID&GP representatives and Chinese manufacturers of biopharmaceutical products took place on the eve of the First China-Russia Forum on Biopharmaceutical Technologies and Business Cooperation. The meeting was also attended by the representatives of the Russian companies. In such a way, Ivan Konoplyannikov, Chairman of the Board of Farmeco Holding, noted his willingness to cooperate with Chinese colleagues, including in the field of equipment manufacturing cooperation and technologies.
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets
- Mutual trust is the fundamental principle of building relationships between the EAEU member countries