Discover Russia with Dokumeds: Regulatory Submission Overview in Clinical Trials

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.

The reality of Russian clinical trials

Generally, Russian laws for clinical trials are completely in line with the relevant industry-specific regulations…

• The local Good Clinical Practice legislation is a word-to-word Russian translation of ICH GCP guidelines.
• Investigators are trained in ICH GCP by Sponsors and CROs
• A local database of clinical trials is publicly available
• Investigative sites have their own independent ethics committees.

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).

The submission process for clinical trials

As  standard practice, foreign sponsors will perform local submissions via their authorized representative in Russia – CRO, consultancy firm, or local corporate office.

• The regulatory process itself is transparent: to initiate a clinical trial, every Sponsor has to obtain approval from the local regulatory authority – Ministry of Health (MoH).
• The submission package includes key study documents: study protocol, patient-related documentation, information about the investigative product, site and investigator information.
• The files have to be translated into Russian and submitted in paper and electronic versions.
• The MoH conducts scientific and ethical expertise of the provided documents, performed in parallel by the Scientific Centre for Expert Evaluation of Medicinal Products and Ethics Council respectively.
• The MoH expertise fee is around 3000 EUR (as per average exchange rate of November 2020). It is paid in rubles in advance of the document submission and the confirmation of payment must be included into the documents package.

Timelines

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).

Regulatory timelines in Russia: comparative overview for 2019

Data Source: Regulatory timeslines in Russia

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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.

Take advantage of Dokumeds’ experience

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!