Since 2005 we have been consulting Sponsors on cooperation with regulatory authorities as well as helping them develop a registration strategy.
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.
- Inclusion of Russia in the international multicenter clinical study involving part of the population of patients from Russian research centers
- Conducting local registration research in Russia
More than 150 received approvals for conducting clinical trials
Successful experience in conducting pre-IND meetings, or meetings with the FDA (U.S. Food and Drug Administration), conducted prior to receiving approval for undertaking clinical trials
Organization and execution of scientific advice meetings with the EMA and FDA
Submitting applications to the FDA for the registration of new experimental drugs
Obtaining orphan drug status from the EMA/FDA
- Document review as part of preparation for a clinical trial application
- Regulatory strategy development
- Clinical Trial approval submission with local regulatory authorities
- Obtaining import/export permits for drug import and export of biological samples
- QP release for EU countries
- Liaison with regulatory experts and regulatory authorities