Delegates of FSI «SID & GP» of the Ministry of Industry and Trade of Russia with an official visit to Singapore towards experience sharing
On October 17, delegates of the Federal State-funded Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia paid an official visit to Singapore aimed at experience sharing. Within the event, meetings with colleagues from some Asian countries were held and manufacturing sites of the top pharmaceutical companies of the market were visited.
Experts of the Institute discussed with their Asian colleagues the topics of cooperation in joint inspections, development of new drug products, growth of drugs export and import between Russia and Singapore.
Russian delegates presented the structure of competent RF authorities and organizations responsible for control of drug manufacture and circulation, implementation of the state policy, and distribution of responsibilities between executive authorities and relevant organizations working in the sphere of medicinal and veterinary drug circulation in the RF.
Before 2015, inspections of pharmaceutical manufactures in Russia were carried out within licensing supervision. In 2015, the practice of mandatory GMP-inspections was officially implemented along with issuance of GMP-certificates to Russian pharmaceutical manufacturers. In 2016, inspections and issuance of GMP-certificates became mandatory for foreign pharmaceutical companies as well.
«As of Q3 2018, in total 1,190 inspections were carried out» — clarified Mr. Vladislav Shestakov, the Director of FSI «SID & GP», in his speech. «An important part of activities of the Institute and the Russian GMP-inspectorate is establishing international cooperation both with individual countries and professional and cross-country alliances and associations. We are actively developing cooperation with such global associations as ISPE, PDA, and DIA. We lay great emphasis on strengthening relations with Singapore and other Asian countries, which will help to improve the quality of drug products manufactured and will eventually enhance the patients’ quality of life.»
Representatives of FSI «SID & GP» also talked about their own and partnership programs on inspectors’ training for systematic career enhancement and compliance with the most stringent requirements both on the local and international level. To conclude, representatives of the Russian delegation and Asian companies discussed the prospects for collaboration in joint training programs, research and scientific publications, and participation of foreign colleagues in the GMP conference in 2019.
On the international level, FSI «SID & GP» eagerly cooperates with the countries of EAEU, Europe, America, Africa, Middle East, Asia and Australia, and is in strong partnership with global alliances and associations, such as WHO, ISPE, PDA, DIA, PIC/S, EMA, ICH.
- The volume of Indian drugs in the Russian market was $770 mln in 2018
- Mr. Vladislav Shestakov called for taking a quantum leap in GLP
- Interaction points were discussed by SID & GP with EDQM
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application