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The EAEU considers the issue of an accelerated procedure for registration of medicines

The EAEU is considering the issue of the registration procedure for generic medicines. Iya Malkina, Assistant to the Chairman of the Board of the Eurasian Economic Commission (EEC), said this at an online briefing, Kazinform MIA reports.

“To prevent a shortage of medicines, the European Union will change its legislation and facilitate the withdrawal of generics into circulation. The European Commission plans to make it easier for patients to access generic drugs that are cheaper than the original. What is the position of the Eurasian Economic Union on this issue? Does the EAEC plan to take such measures? " - asked at the briefing.

Iya Malkina replied that at present, the legislation of the Eurasian Economic Union includes procedures for accessing the market for generic or copied medicines based on studies of their bioequivalence. At the same time, for a number of drugs, instead of bioequivalence studies, it is allowed to submit studies to simulate the test of comparative dissolution kinetics in laboratory conditions, which reduces the program for the development of such drugs and the timing of their introduction to the market.

“As part of improving the legal regulatory framework of the Union, the Commission is working on the initiatives of the parties, which are related to the registration procedure under the new conditions of accelerated access and a number of others. Some of these procedures can be applied, including to medicines from the group of generic or copied medicines” added Iya Malkina, Assistant to the Chairperson of the Board of the Eurasian Economic Commission.

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