For years, Russia has been considered an attractive destination to conduct clinical trials. The country’s population of more than 144 million people combined with a centralized healthcare system provides extensive patient enrollment opportunities. In a world in which recruitment is the biggest cause of delay for clinical trials, this is a huge benefit.
However, some sponsors are hesitant to include Russian investigative sites in their multinational clinical studies. Unfamiliarity with local regulations is among popularly named reasons. Commonly held misconceptions- including a lack of safety precautions- prevent companies from utilising Russia in their work.
Generally, Russian laws for clinical trials are completely in line with the relevant industry-specific regulations…
According to Dokumeds’ 15 years of experience, Russian sites demonstrate high recruitment figures and consistent quality of work. FDA has conducted 112 site inspections since 1995 with only 1 resulting in “Official Action Indicated” (OAI).
As standard practice, foreign sponsors will perform local submissions via their authorized representative in Russia – CRO, consultancy firm, or local corporate office.
Official timeline for regulatory expertise by MoH is 57 calendar days. As per Dokumeds’ experience, this timeline is achievable and realistic, provided that the submission package is complete.
Our team actually managed to keep the average timeline for 2019 submissions even shorter – at only 56 days. Compared to reported by ACTO members (Russian Association of Clinical Trials Organizations) average of 87 days, this figure stands out as indication of the quality of our on-the-ground regulatory team in Dokumeds’ Russian office.
After the MoH study approval is in place, the study team can apply for an import license for the Investigative Product and export license for biological samples. The licenses applications are done free of charge, but require separate document packages. MoH official review timelines are 12/19 calendar days (for import/export).
Data Source: Regulatory timeslines in Russia
The final requirement before starting study enrollment is receiving approvals at Local Ethics Committees (LECs). LECs are present in all major investigative sites and usually convene on a monthly basis. They may charge a fee of around 500 EUR for study approval. This process is performed in parallel with import/export license applications in order to save time.
Clinical study conduct in Russia opens a lot of opportunities for the international pharma/biotech companies. These include: fast subject enrollment, access to a treatment-naïve patient pool, competent and motivated English-speaking investigators, high-quality trial data, competitive project costs, option to receive local marketing approval. A lack of familiarity with the regulatory system and local specifics can be easily overcome by choosing the right CRO partner.
Dokumeds is an ISO-certified CRO operating in Russia since 2005 and an active member of ACTO. The company has an office in Moscow and a local GDP-certified warehousing facility for study supplies storage and distribution. A dedicated Study Start Up Group is functioning to optimize trial initiation processes and bring projects to life within the shortest possible timelines. To know more Book a call with us today!