Drug Registration

As per Federal Law “On Circulation of Medicines” #61-FZ of 12-Apr-2010, the following products are subject to the state registration in Russia:

  • all medicines for the first time entering into circulation in Russia (original / brand-name products and reproduced  drugs / generics, bioanalogues)
  • new combinations of previously registered drugs
  • new formulations and dosages of previously registered drugs

State registration of drugs is carried out by results of examination of medicines that includes:

1) documents’ expert review to determine whether to consider drug as orphan;
2) medicines quality examination, i.e. expert analysis of proposed quality control methods and drug samples;
3) expert assessment of expected benefits – potential risks ratio.

Since 2016, drug registration dossier in Russia is provided in the form of common technical document (CTD). Moreover, in accordance with the law amendments, a Russian GMP certificate is to be included into registration dossier; that is a copy of the report on the compliance of the manufacturer of medicines to the requirements of the rules of good manufacturing practice, issued by the Ministry of Industry and Trade of the Russian Federation. 

Each drug form is submitted in a separate registration dossier. However, several dosages, strengths, and volumes can be included in one dossier for the same drug form.

Since 2016, marketing authorization holder (MAH) should provide pharmacovigilance (PVG) reports to the Roszdravnadzor (Federal Service for Surveillance in Healthcare) once every six months during two years after drug state registration in Russia, then - annually in the next three years, and thereafter every five years.

 ARS offers its Clients the following services:

  • medicinces’ registration dossier preparation 
  • consulting on drug registration issues
  • compiling a list of required documents
  • adaptation of documentation provided in compliance with the Russian legislation
  • development of individual documents of registration dossier
  • primary and secondary packaging mock-up preparation
  • registration dossier submission to competent authorities (Ministry of Health)
  • organizing and conducting necessary preclinical and clinical research
  • comparative dissolution testing
  • obtaining permits and handling official queries and resolutions
  • preparing answers, reports in accordance with queries
  • organizing pre-registration expert analysis of proposed methods of drug quality control and drug samples
  • organizing drug quality examination and expert assessment of expected benefits relative to potential risks of a drug use
  • obtaining a registration certificate and approved documentation for a drug

Moreover, ARS provides registration services such as:

  • variations (modification of registration dossier of already marketed drugs)
  • renewals (drugs’ re-registration)
  • registration of maximum selling price of medicines from the Vitally Needed Essential Drugs List
  • inclusion of pharmaceutical substances into the state drug registry
  • registration of food supplements at the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor)

In accordance with 61-FZ, drug registration cannot exceed 160 working days, excluding time to answer questions of the MoH experts (90 working days).