Amendments to Federal Law No. 61-FZ “On Circulation of Medicines” of April 12, 2010, come into force on January 1, 2016, and extend the requirements for information submitted by applicants in drug registration dossiers. The introduction of the new requirements necessitates the preparation of guidance materials concerning various sections of the registration dossier, including those for drug excipients. Regulations of the EU, USA, Japan, and Russia and the database of the Scientific Center for Expert Evaluation of Drugs were compared in order to justify the adopted approach to excipient quality assessment. In this article, current requirements for quality assessment of excipients at the drug registration stage in Russia and abroad were discussed.

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