Presentation at the IV Eurasian Economic Congress
December 6, 2017 the IV Eurasian Economic Congress, dedicated to the current issues of business development in the countries of the EAEU, has been held in Moscow.
The Congress is a platform for direct dialogue between the business community, the Eurasian Economic Commission, the authorities of the Eurasian Economic Union’ member states, professional and public organizations of the EAEU countries and their partners.
During the event, the session “Unified Market of Medicines of EAEU – From Formation to Law Enforcement” was held, in which the following issues were actively discussed:
- Effective regulatory policy in the sphere of medicines circulation as a tool for Eurasian integration. Harmonization of approaches to regulation and enforcement.
- The process of requirements and procedures implementation of the unified market of medicines in the national regulatory systems of the EAEU member states.
- Evaluation of the readiness of regulators, expert organizations of the EAEU member states, as well as medicines circulation’ entities to work on requirements and unified market procedures.
- The unified informational system in the sphere of medicines circulation.
- New opportunities for the development of the pharmaceutical market of the EAEU.
This session was attended by Vladislav Shestakov, Director of FSI «SID and GP», where he spoke on the possibilities for integrating global associations applying the example of interaction between inspectorates: “The important basis for the development of a unified market is the issue of trust, which is at the forefront of the interaction between professional teams of inspectorates. At the meeting of the Eurasian Economic Commission, which was held on November 16-17 this year, the agreement on establishment of an acting on the ongoing basis working group on pharmaceutical inspection under the EAEU has been reached. The group will have to work out in detail issues related to the requirements for educational programs, training of inspectors on joint inspections, development of a unified non-conformities classification, and creation of mechanisms for transparency of reports. In case these mechanisms are effectively implemented and fulfilled, the integration process of the EAEU will be most comfortable for all participants”.
- 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
- Giuseppe Fedegari: «The shortcut to training: working with people who already have the experience»
- FSI «SID & GP» is holding a training workshop with international participation for pharmaceutical inspectors
- On 07 February, a new solids manufacturing facility was launched by the «Obolenskoe» Pharmaceutical Enterprise