article
30.08.2019

What should you know before filing regulatory submissions for clinical trials in Russia?

In terms of the current legislation the key elements to be aware of in filing regulatory submissions in Russia are outlined below:

• Regulation of the state registration of new drugs in Russia is established in detail by the current law
• Phase I first-in-man clinical trials in healthy volunteers cannot be conducted in Russia for drugs manufactured outside Russia
• New requirements to clinical trial insurance are applicable
• Principal investigators must have a minimum of 3 years of experience in clinical trials
• Companies are required to repeat bioequivalence and therapeutic equivalence studies in Russian patients in order to obtain generic drugs registered in Russia. The reference drug should be registered in Russia and should be purchased locally
• According to regulations, a registration dossier for a generic drug should include a pre-clinical package for the reference drug as well as investigational drug
• There are two routes to obtaining marketing authorization for a drug in Russia:

1. Inclusion of Russia into a multi-national multi-center clinical trial, enrolling a proportion of study patients from Russian sites
2. Conduct a local registration study in Russia (in this case, the drug registration dossier must be submitted prior to the application for the clinical trial approval being made with the MoH)

Strong local expertise, provided by the OCT in-house drug registration specialists, allows OCT to address a wide range of current regulatory issues in Russia. Furthermore, through highlighting different regulatory strategies to their clients, OCT can provide optimal solutions for rapid market authorization in Russia.