03.Jul.2012

OCT article has been published in a distinguished specialized magazine

The topic covered in the item is of interest for a majority of pharmaceutical and biotechnology companies aiming at Central and Eastern European markets, especially Russia. he major regulatory body is the Ministry of Healthcare

OCT has written an article for a distinguished specialized magazine CenterWatch Monthly. The topic covered in the item is of interest for a majority of pharmaceutical and biotechnology companies aiming at Central and Eastern European markets, especially Russia. Below, you may find the full text of the article. "What are the major changes implemented by the new law in Russia?"

How many times have we heard this question from pharmaceutical and biotechnology companies! Indeed, Central and Eastern Europe is gaining an increasing interest of the pharmaceutical industry in terms of drug marketing and, logically, clinical trials conduct. A thorough understanding of the new law, as well as its correct interpretation, is crucial for companies that target the Russian market.

The underlying guidelines are engraved in the Federal Law No. 61-FZ On the Circulation of Medicines as of April 12, 2010 (certainly, there also are other regulatory enactments). The law has introduced several changes:

  • The major regulatory body is the Ministry of Healthcare. The principle of the so-called "one agent" has been implemented, i.e., all documents are submitted to the MoH, namely, the Department for State Regulation of Medicinal Products, and then are reviewed by the Scientific Centre for Evaluation of Medicinal Products and the Ethics Council
  • Trials in Russia can be conducted either as part of a multinational clinical trial or within the registration process
  • To get a novel drug registered in Russia, it is necessary to provide the results of international multi-center clinical trials of the medicinal product for medical use, partially conducted in the Russian Federation
  • In order to participate in clinical trials, the Principal Investigator is required to have at least five years of experience in the sphere
  • Medical institutions should have a special, new accreditation procedure if they plan to participate in clinical trials. The full list of the sites is available in the special registry list regularly published and updated by the MoH on its website page

Additional amendments and changes to the current law might be considered by regulatory authorities.

OCT is open for sharing its knowledge and expertise with all the interested parties.