By Janis Brix, CEO of Wigwa
Russia has become a viable and attractive destination for conducting clinical trials, primarily because of the vast population, advancements in treatment and diagnostics, as well as a large pool of qualified investigators. While international firms prefer to do clinical trials in Russia, regulatory and logistical requirements remain a major impediment.
Most of the clinical trials approved in Russia in 2020 required investigational Medicinal Products (IMPs) and the approval or export of other trial biological samples/clinical trial supplies.
These regulatory and logistical hurdles emphasize the essence of clinical trial supply and logistics in conducting successful trials in Russia. A balance of essential variables, such as taxes and service costs, regulatory and transport, is a critical tenet to successful clinical trial supply and logistics management.
How to achieve efficient clinical trial logistics in Russia
Importation of IMPs
The regulatory framework in Russia can complicate the importation of IMPs for a clinical trial in Russia. Companies apply for import licenses subject to the approval of the clinical trials by the Russian Health Ministry.
Some of the required documents for the license application include drug label, certificate of analysis, and application. Companies must justify the quantity of IMPs imported, extracts from the trial protocol, and a copy of the study’s approval.
A power of attorney is required where a local agent represents a sponsor.
Regulations on the imports of clinical trial supplies
Clinical investigations of medicinal products in the Russian Federation are regulated by the Federal Law of the Russian Federation No. 61-FZ of April 12, 2010 “on Circulation of Medicines.” Other regulations include the federal law of the Russian Federation of November 21, 2011, No. 323-FZ “About bases of protection of public health in the Russian Federation,” the tax code, and several government decrees and orders.
Companies are required to produce export licenses while exporting biosamples for testing and processing outside the Russian Federation. They should provide accurate information on the number of containers, tissue type, and the quantity of samples for export.
The documents need to align with the export license requirements and be justified by the study protocol. All biosamples export/import details are enumerated in the government decree No 673 of September 03, 2010 “Approval of rules for import and export of biological materials obtained in clinical trials of a medicinal product for medical use into and from the Russian Federation.”
Import of general medical samples
Companies need to comply with the tax and duty requirements when importing general medical supplies, even though special licenses are unnecessary in Russia. The certifying body or the agency for technical regulation to import medical equipment requires a letter of exemption. A company seeking to import electronic devices may notify the Federal Security Service.
While foreign companies/sponsors can purchase clinical trial supplies from the Russian local market, they may not be familiar with the local suppliers. Therefore, they may opt to import such supplies, an issue that often inflates the general cost.
Companies should have a well-thought-out plan to conduct a clinical trial in Russia, given the several regulatory requirements for importing medical samples.
How to navigate custom clearance
There is a need to consider all the costs when planning clinical trial logistics in Russia. Any company seeking to import supplies into Russia must undergo the custom procedures. Although such a process is done electronically, the documents must be in Russian. Importers require an accurate Pro-forma invoice to facilitate customs clearance.
How Dokumeds can facilitate the supply logistics in Russia
As a CRO with over 20 years of operation in Russia, Dokumeds has the requisite experience and expertise to overcome the country’s clinical trial supply and logistics challenges. Companies can achieve operational success and optimize supply and logistics management by partnering with Dokumeds. Their warehouse is certified and compliant with Good Distribution Practice (GDP) and ISO 9001:2015. Also, Dokumeds has access to local suppliers and can help sponsors with the clinical trial and logistics.