06.Sep.2012

OCT throws light upon the latest trends in clinical research and drug registration regulatory situation in Russia

The main focus is on the latest FAS proposal to revise law the Circulation of Medicines (#61-FZ of 12-Apr-2010) so that to increase competition in the market. Hope, this will be interesting for all types of industry players. Please find below the full text of the article.

Dear Colleagues,
You are welcome to review OCT’s article published in the September’s Issue of the CenterWatch Monthly. In the publication OCT expresses its view on the recent regulatory changes in clinical research and medicinal products registration and how these should affect the Russian pharmaceutical market in total. The main focus is on the latest FAS proposal to revise law the Circulation of Medicines (#61-FZ of 12-Apr-2010) so that to increase competition in the market. Hope, this will be interesting for all types of industry players. Please find below the full text of the article.

“FAS Russia supports competition”

The Russian market is waiting for the Ministry’s of Healthcare (MoH) response to the Federal Antimonopoly Service’s (FAS Russia) suggested amendments to incorporate into law the Circulation of Medicines.

The FAS proposal to revise the main code regulating clinical trial approval and drug marketing authorization in Russia was published in spring 2012. It contains the following key points designed to streamline and harmonize relevant activities:

  • separating the clinical trial approval process from drug registration procedure and cancelling repeated filing of the application for clinical study
  • abolishing mandatory local research and accepting the results of GLP and GCP compliant international trials
  • implementing accelerated registration for orphan and generic drugs
  • specifying generics registration and registration dossier amending
  • cancelling accreditation of investigative sites and reducing the minimum requirement for principal investigator experience
  • defining radiopharmaceuticals
  • approving pediatric clinical trials only when a drug is prescribed for infants.

The FAS supports the initiatives aimed at determining substitutability of medical products and including this information in the state register; introducing mandatory prescriptions of medicines only according to the INNs; developing a state program to stimulate use of generics and eliminate imposing expensive drugs on consumers; and revising the technique of fixing the ultimate selling prices of the drugs from the List of Vitally Needed and Important Medicines.

A number of other executive and legislative authorities support the FAS proposals. Nevertheless, the final decision rests exclusively with the MoH.

We expect the changes will be implemented shortly, as Russia has prioritized standards harmonization with international rules. The overall estimated impact will be greater regulatory transparency and increased competition among pharmaceutical and biotechnology companies, CROs, expert organizations and investigative sites, which ultimately will result in lowering the cost to enter the Russian market”.

By the moment OCT has received tens of clinical trials’ approvals in Russia and other countries of CEE.
Our regulatory department has gained solid experience of applying both within international and local registration clinical studies. We have even supported one of our Clients to receive orphan drug status in EU.
Please contact us if case you look for clinical research regulatory consultancy in CEE region. We would be happy to help you!