Russia, due to its vast population, availability of qualified investigators, and advanced diagnostic and treatment possibilities has turned into an attractive destination for conducting clinical trials. Many international companies are choosing Russia for their clinical trial activities; however, there remain challenges with the regulatory and logistics requirements.
In 2020, over half of all clinical trials approved in Russia required Investigational Medicinal Products (IMPs) and other trial supplies/biological samples to be either imported or exported. This brings to the spotlight the crucial role that supply chain management plays while planning clinical trials in Russia. Efficient clinical trials supplies management requires careful balance of transportation times, regulatory aspects, taxes as well as service costs.
Supply chain management in clinical trials is an increasingly important and complex task. While conducting a clinical trial in Russia, it is imperative to thoroughly understand the clinical trial process to ensure smooth implementation of the planned process and to get a better estimate of the overall budget, timelines.
Below are some important points to note while planning a clinical trial in Russia.
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.” Apart from this, 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 are other requirements that need to be complied with.
When conducting clinical trials in Russia, importing IMPs can be the most lengthy and cumbersome process. Once the approval to conduct a clinical trial is granted by the Russian Ministry of Health, companies need to apply for import licenses to ship any IMPs into the country.
Application letter, certificate of analysis and drug label are some common documents which need to be submitted while applying for a license to import IMPs. Companies also need to share a justification for the amounts of IMPs required, extracts from the protocol outlining the drug’s name and dosage regimen and copy of the study’s approval. In cases where a local representative is acting on behalf of the sponsor, a power of attorney is required.
During clinical trials, biological samples may need to be sent to other countries for processing and testing. And just like importing IMPs, exporting biosamples mandates an export license.
Documents that accompany biosamples shipments should include information on the amount of sample, the tissue type, and the number of containers. The requirements should be justified by the study protocol and needs to be in line with export license conditions. Also, all descriptions regarding the containers, such as the quantity, need to be accurate. All details for biosamples export/import are enumerated in the government decree No 673 of 03 September 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”.
In Russia, no special licenses are required while importing medical supplies and equipment, however standard custom duties and taxes are still needed. Additionally, importing medical equipment may require a “Letter of exemption” by the certifying authority or the agency for technical regulation. Importing electrical devices may also require notifying the Federal Security Service. These additional steps make the process lengthy and complex and highlight the need to meticulously plan the various equipment and devices required at various stages of the clinical trial.
In most cases, equipment, laboratory-grade containers, and reagents can be purchased from the local market. However, due to the lack of familiarity with the local market and suppliers, many foreign sponsors end up importing these products which eventually adds to the cost.
When planning clinical trial logistics, it is important to consider all potential costs and bottlenecks. All items imported into Russia are subject to customs procedures. Handling customs and import duties is an unavoidable part of any import process. The customs declaration process is handled electronically in Russia and is hence easy to track, but all documents need to be in Russian. The need for an accurate Pro-forma invoice for the importation process is another requirement for smooth processing of customs clearance. Inaccurate Pro-forma invoices, customs declaration, or categorization of products are some possible tasks that may delay the customs clearance process.
Clinical trials supplies management in Russia poses unique challenges. Dokumeds, with its expert and professional team, is a CRO with over 20 years of experience working in Russia. By partnering with Dokumeds, companies can optimize the supply logistics process and improve their operational effectiveness and outcomes.
Dokumeds possess the knowledge and systems which help companies navigate the supply logistics process seamlessly. Familiarity with customs processes and access to a pool of local vendors are other added advantages. Dokumeds’ warehouse is certified and compliant with Good Distribution Practice (GDP) and ISO 9001:2015.
To learn more regarding the various regulatory and logistic requirements when setting up a clinical trial in Russia, download our e-book now!
The e-book, prepared by Dokumeds’ team of experts, outlines the key requirements, and offers practical tips on how to efficiently manage the supply chain and ensure timely import and delivery to sites.