Establishment of the single EAEU market remains one of the most discussed topics in the context of good practices development.

In this respect, the V All-Russian GMP Conference initiated a special panel discussion, Present and Future of the EAEU Countries Single Market Integration. Teva Company, one of the conference partners, will participate in the discussion. Margarita Mustafina, Quality Director at Teva, Russia and Eurasia, will present her position on such matters as the development and implementation perspectives for the integrated drug labelling system in the EAEU market, establishment of integration mechanisms, correlation between the Eurasian and national requirements.

Being a leader in the global pharmaceutical industry, Teva operates both in Russia and other EAEU member-states. The company has strong expertise in sphere of research and development, advanced production technologies, overall compliance with laboratory (GLP), manufacturing (GMP) and clinical (GCP) practice standards; it is a regular participant of progressive pharmaceutical initiatives. Thus, for instance, in 2016 Teva was one of the first companies to apply for conduction of GMP inspections.  During 2016-2017, the company filed applications in relation to almost all existing manufacturing facilities, and as of today, they have all been confirmed for conformity to GMP standards.

Apart from that, Teva took active part in the Individual Drug Labelling project as part of the working group organised under the aegis of Roszdravnadzor. As part of this initiative, the company openly discussed the matters of the labelling system implementation in coordination with the government agencies, pharmaceutical associations and other market representatives.

“For the purpose of efficient cooperation in the Eurasian market when implementing the drug labelling requirements, the Eurasian Economic Commission has to develop consistent requirements to the means of identification and data transfer to assure the traceability of medicinal products circulation,” says Margarita Mustafina.

This year, Teva has been working on the preparation and submission of several registration dossiers for new drug products in compliance with the EAEU requirements.

The company believes that the implementation of good practices at all production cycle stages is the crucial component of the pharmaceutical industry development. The ultimate objective of all initiatives, starting with practice improvement and ending with the establishment of the EAEU single market, is to assure the health of patients and to improve the quality of life by satisfying the healthcare needs for innovative products that comply with high quality and safety criteria.

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