Discover Russia with Dokumeds: regulatory submission overview in clinical trials


For years Russia has been an attractive destination to conduct clinical trials. The country’s population of more than 144 million people combined with centralized healthcare system provide vast patient enrollment opportunities. However, some Sponsors are still hesitant to include Russian investigative sites in their multinational clinical studies. Unfamiliarity with local regulations is among popularly named reasons. 

Dokumeds’ 15 years of experience 

Generally, Russian laws for clinical trials are in line with the relevant industry-specific regulations. For example, 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 publically 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 111 site inspections since 1995 with only 1 resulting in “Official Action Indicated” (OAI). 

Image: FDA Inspections results

Submission process for clinical trials 

As a standard practice, foreign Sponsors 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 April 2019), it is paid in rubles in advance of the document submission and the confirmation of payment must be included into the documents package. 

Realistic and achievable 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 managed to keep an average timeline for 2018 submissions even shorter – at only 55 days. Compared to reported by ACTO members (Russian Association of Clinical Trials Organizations) average of 92 days, this figure stands out as an important achievement and evidence of a competent and experienced 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). 

Image: Regulatory timelines 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, usually convene on a monthly basis and 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 offer new opportunities  

Clinical study conduct in Russia opens a lot of opportunities for the international pharma/biotech companies: 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. 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 international ISO-certified CRO operating in Russia since 2005 and is an active member of ACTO. The company has two offices in Moscow and St Petersburg 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. 

 


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