31. October 2015

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...