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Wednesday, 21 February 2018
ACPS\' Expertise on BABE-studies in the Russian Federation

New legal provisions for the marketing authorisation of multi-origin medicinal products ("generics") in the Russian Federation are now well in place since Sep.2010. One of the most important immediate implications is the need to conduct bioequivalence studies in Russia in accordance with the pertinent laws. directives and methodological standards. These provisions are different from the now more or less harmonised EU/US-regulatory framework.

Throughout 2011, ACPS has made an in-depth analysis of the resulting challenges and opportunities mainly from the perspective of western sponsors and applicants. We have prepared a summary and analysis of the resulting regulatory provisions and have visited several service providers (including investigational sites and laboratories).

We are happy to share this information and the resulting recommendations with interested parties also to increase the probability of success and to improve the time- and cost-efficiency of such ventures.

For further information:

Applied Clinical Pharmacology Services

* Philippsring 11 * 55252 Mainz-Kastel * Germany * phone: +49/61 34 - 180 467 or 469 * fax: +49/61 34 - 180 468 *

ACPS International Ltd.-Bulgaria

* 1113 Sofia * 15 "Kosta Lulchev" Str., ap. 9 * phone: +359/2 979-7970 * fax: +359/2 979-7971 *