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Quality Assessment of Excipients at the Drug Registration Stage

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Pharmaceutical Chemistry Journal Aims and scope

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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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation, Moscow, 127051, Russia, Petrovskii Blvd., 8

    M. M. Mironova & E. L. Kovaleva

Authors
  1. M. M. Mironova
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  2. E. L. Kovaleva
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Correspondence to M. M. Mironova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 49, No. 6, pp. 34 – 39, June, 2015.

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Mironova, M.M., Kovaleva, E.L. Quality Assessment of Excipients at the Drug Registration Stage. Pharm Chem J 49, 393–397 (2015). https://doi.org/10.1007/s11094-015-1291-z

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  • DOI: https://doi.org/10.1007/s11094-015-1291-z

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