01.07.2015

As per 429-FZ of 22-Dec-2014 new amendments to the Federal Law “On Circulation of Medicines” #61-FZ have come into the force in Russia.

Since 01 of July 2015 orphan drug designation procedure has been implemented; no more local clinical trials results are required for orphan drugs registration in Russia, now on foreign clinical data is sufficient for marketing authorization purposes; accelerated registration process for orphan medicines is applicable in the country from date. As from now PI experience has been decreased from five to three years as a requirement to participate in clinical research in Russia; this definitely extends the pool of potential investigative sites in the country. Since 01 of July 2015, scientific consulting is to be introduced under the direction of the Russian Ministry of Health; Russian biopharmaceutical research society pins its hopes on this legislative innovation. Since the date duplicated clinical trial application procedure is to be abolished in Russia as well.

As per the law, more important amendments will come into the force since 2016. CTD (Common Technical Document) will be implemented in Russia; in due time all the registration dossiers of new and already registered drugs are to be transferred to CTD format. Requirement for providing own preclinical results within the registration dossier will be canceled for generics and combination products (if the same structure / content as in the reference drug and no influence of excipients on safety / efficacy).  New definitions like biologics, bioanalogues, reference products, interchangeable medicines, immunobiologics, gene therapeutics, etc. are becoming effective. Local therapeutic equivalence clinical studies for generic injectables and sprays (with some reservations) are abolished as well in Russia since 2016.  Since next year in Russia data exclusivity will be four years for reference pharmaceuticals / three years for reference biologics plus marketing exclusivity will be two years for reference pharmaceuticals / three years for reference biologics. The full list of legislative amendments in Russian can be found here (429-FZ)