International workshop in Vienna

23 октября, 2019

On October 16-17, was the International workshop on the implementation of new requirements for registration of medicines on the territory of the Eurasian Economic Union (EAEC) held on. Representatives of the companies from Russia, Kazakhstan, Belarus, Armenia, Azerbaijan, as well as other CIS countries visited Vienna to exchange experience and knowledge, discuss key questions and relevant topics in the sphere of the pharmaceutical industry.

Key changes in the approach to drug registration, as well as the functioning of the Pharmacovigilance system were considered, during the event. The participants of the workshop exchanged the first successes and difficulties in working, according to the new standards.

The key issues discussed at the event where the organization of GMP inspections by the authorized bodies of the participating countries and the process of harmonization of product files to a single format in all countries.

A special discussion among the participants was caused by the issue of reconciliation of different production chains at centralized registration throughout the EAEC.
In view of economic feasibility, certain stages (secondary packaging, production of the series) can be conducted at local companies by the ENPP states members. The discussion resulted in a formal request letter to the regulatory authorities to explain a possible action strategy for all interested market participants.

In addition, special attention was paid to the issues of strategy development and risk minimization in the harmonization and transfer of pharmaceutical company product portfolios to new unified regulatory requirements.