The issues of Russian legislation harmonization with EAEU law were discussed by the participants of the round-table discussion on the topic «Regulatory environment of drug manufacture-related cooperation»
On 23 October, the Director of FSI «State Institute of Drugs and Good Practices» Mr. Vladislavl Shestakov took part in the round-table discussion on the topic «Regulatory environment of drug manufacture-related cooperation: the issues of Russian legislation harmonization with EAEU law». This round-table meeting was organized by the Institute of Legislation and Comparative Law under the Government of the Russian Federation.
The resolutions of the Eurasian Economic Commission (EEC) in the sphere of drug circulation which became effective in May 2016 are direct-force acts within the Russian Federation territory. Addressing the participants of the round-table discussion, the Director of FSI «SID & GP» Mr. Vladislav Shestakov pointed out that provision of high-quality and effective drugs to the public is one of the major social tasks for any country. And to start implementing the resolutions of EEC, regulatory authorities of EAEU member states need to develop national laws and regulations harmonized with resolutions of the Eurasian Economic Commission.
«Development of such regulations will enable us to create the mechanisms for implementing the supra-national acts, which will inevitably clear up the ambiguity in the regulatory environment in terms of inspections» — emphasized the Director of FSI «SID & GP» Mr. Vladislav Shestakov in his speech. «Harmonization of the national legislation with EAEU law will be the next step towards recognition of inspectorates of EAEU member states and, subsequently, the results of pharmaceutical inspections on a global level. This will foster strengthening of trust in the results of pharmaceutical inspections and striving for mutual recognition of GMP-certificates.»
Currently, the Institute together with the Ministry of Industry and Trade and Roszdravnadzor are actively engaged in PIC/S accession activities. This will allow cooperation of inspectorates of all PIC/S member states in advancement of good practices and will be a platform for experience sharing and training of inspectors. To conclude, Mr. Vladislav Shestakov expressed his hope that the results of the round-table discussion would structure the jointly shared position for the most rapid establishment of the common market of medicinal drugs.
- 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