Consulting and Regulatory Support
OCT has both strong regulatory expertise and longstanding relationships with key opinion leaders across the regions in which we operate. This allows us to be confident in our approach to obtaining local regulatory approval for our customers’ studies. OCT provides full regulatory support in Russia, Central and Eastern Europe and the US:
- Document review as part of preparation for a clinical trial application
- Regulatory strategy development
- Clinical Trial approval submission with local regulatory authorities
- For Russia, Ukraine and Belarus: obtaining import/export permits for drug import and export of biological samples
- QP release for EU countries
- Liaison with regulatory experts and regulatory authorities
Our regulatory expertise includes:
- 92 submissions for study approvals
- successful experience in pre-IND meetings with FDA
- organization and conduct of scientific advice meetings with EMA
- IND submission with FDA
- obtaining orphan drug status in EMA
Previous legislation around clinical trial conduct in Russia was often a cause for concern to international companies. However, the signing of a new Federal Law in 2010 has improved the situation for companies wishing to run studies in the region. Together with a number of accompanying decrees, orders and bylaws, the new Federal Law introduced changes to the drug registration process, some of which effect procedures connected with the approval and conduct of clinical trials in Russia.
Since 2010, when the new Federal Law “On the Circulation of Medicines” came out, OCT has received no refusals from the Ministry of Healthcare of the Russian Federation when submitting study approvals.
OCT also have the same level of success in obtaining approvals across the countries in which we run clinical studies.
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 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:
- Inclusion of Russia into a multi-national multi-center clinical trial, enrolling a proportion of study patients from Russian sites
- 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 our 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 our clients, OCT can provide optimal solutions for rapid drug registration in Russia.
OCT is your trusted partner in Russia, Central and Eastern Europe and the US.
Please contact us to learn more about OCT services.