{"id":923,"date":"2018-07-30T14:30:00","date_gmt":"2018-07-30T06:30:00","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=923"},"modified":"2021-09-21T16:57:43","modified_gmt":"2021-09-21T08:57:43","slug":"russia-clinical-trial-regulatory-process","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2018\/07\/30\/russia-clinical-trial-regulatory-process\/","title":{"rendered":"Russia &#8211; Clinical Trial Regulatory Process"},"content":{"rendered":"\n<p><strong>Russia<\/strong> has become an increasingly attractive venue for conducting clinical trials for international pharmaceutical companies. Russian clinics and principal investigators have proven to be highly capable of conducting clinical research at a level of quality not less than that of investigators in Western Europe and North America.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/credevo.com\/articles\/\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-300x161.jpg\" alt=\"\" class=\"wp-image-924\" width=\"707\" height=\"379\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-300x161.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-768x411.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-1024x548.jpg 1024w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-732x392.jpg 732w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo-1140x610.jpg 1140w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_clinical_trial_regulatory_process_credevo.jpg 1920w\" sizes=\"(max-width: 707px) 100vw, 707px\" \/><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical trials in Russia<\/h2>\n\n\n\n<p>Sponsors are considering Russia as an attractive venue for clinical trials due to the higher enrollment, patient retention rates, and lower overall cost. A recent report shows that sponsors are satisfied with the results of their clinical trials run in Russia however there remains unfamiliarity with the somewhat unpredictable regulatory environment.<\/p>\n\n\n\n<p>Currently, all major pharmaceutical companies are preferring to conduct clinical trials in Russia and approve their products worldwide based on clinical data received from Russian investigational sites.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote has-text-align-left is-layout-flow wp-block-quote-is-layout-flow\"><p><em><span data-preserver-spaces=\"true\">Are you looking for regulatory support in various stages of drug development? write to us at&nbsp;<\/span><\/em><a class=\"_e75a791d-denali-editor-page-rtfLink\" rel=\"noopener noreferrer\" href=\"mailto:helpdesk@credevo.com\" target=\"_blank\"><em><span data-preserver-spaces=\"true\">helpdesk@credevo.com<\/span><\/em><\/a><em><span data-preserver-spaces=\"true\">&nbsp;or provide your query in the form below<\/span><\/em> or <em>or explore <\/em><a href=\"http:\/\/clinicalstudynetwork.com\/beta_\/clinicaltrials\/clinical-development-strategy\/\"><em>Credevo clinical development services<\/em><\/a><em> <\/em><\/p><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\">Top advantages of clinical trials in Russia<\/h2>\n\n\n\n<p>There are a multitude of factors that influence companies decisions to open clinical operations in Russia for all types of clinical trials: some of them are<\/p>\n\n\n\n<blockquote><p><strong>Russia Clinical Trial Advantages<\/strong><\/p><ul>\n<li>Data acceptance<\/li>\n<li>Patient pool<\/li>\n<li>Relevant investigators&#8217; expertise, and<\/li>\n<li>Cost-efficiency<\/li>\n<\/ul><\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Data acceptance<\/h3>\n\n\n\n<p>With adherence to global standards and regulations observed in clinical studies, The FDA and EMA accept data from such clinical trials in Russia.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Patient pool<\/h3>\n\n\n\n<p>The Russian hierarchical health care system contains a large number of health care facilities across the country which provides substantial access to various patient populations and enables rapid recruitment of study participants. Genetic diversity and high urban proportion<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Investigators expertise<\/h3>\n\n\n\n<p>Access to educated, experienced, and compliant investigators who are motivated to participate in clinical trials to advance new drug development. There are GCP-trained and certified Investigative Sites generating high-quality data.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Lower Costs<\/h3>\n\n\n\n<p>Russia offers lower costs for conducting clinical trials as compared to the US and Western Europe. Some of the experts have claimed that compared to the US, Russian sites offer approximately 30-60% savings to sponsors depending on the complexity of the study, study-specific procedures, patient population, and etc.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><a href=\"https:\/\/credevo.com\/articles\/2020\/02\/15\/rare-diseases-regulatory-incentives-for-development-of-orphan-drugs-china-india-russia-south-korea\/\"><em>Click here to learn about various regulatory incentives and financial benefits provided by Russian regulatory for orphan drug development<\/em><\/a><\/p><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\">Major Therapeutic areas<\/h2>\n\n\n\n<p>There are many unmet medical needs in the region, particularly in the treatment of non-communicable diseases and lifestyle disorders, such as<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Cardiovascular diseases,<\/li><li>Diabetes and<\/li><li>Cancer followed by other therapeutic areas<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Regulatory bodies<\/h2>\n\n\n\n<blockquote><p>Main regulatory bodies in Russia for clinical trial processes are as follows<\/p><ul>\n<li>Ministry of Health Care and Social Development<\/li>\n<li>Federal Service for Supervision in Health Care and Social Sphere<\/li>\n<li>Scientific Center of Expertise of Medicines and Medical Devices<\/li>\n<li>National Ethics Council<\/li>\n<li>Medical Institutions<\/li>\n<\/ul><\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Ministry of Health Care and Social Development<\/h3>\n\n\n\n<p>Takes care of<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Accreditation of medical Institutions,<\/li><li>Approval of clinical trials,<\/li><li>Information services related to clinical trials,<\/li><li>Relations with the medical community<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Federal Service for Supervision in Health Care and Social Sphere<\/h3>\n\n\n\n<p>Takes care of<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Supervision of clinical trials,<\/li><li>Inspections in clinics,<\/li><li>Pharmacovigilance<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Scientific Center of Expertise of Medicines and Medical Devices<\/h3>\n\n\n\n<p>Undertakes review of clinical study documents<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">National Ethics Council<\/h3>\n\n\n\n<p>Responsible for ethics supervision of clinical trials<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Medical institutions<\/h3>\n\n\n\n<p>Responsible for GCP compliance, Clinical trials reports, Local ethics committees, and SAE reporting<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Requirements &amp; process<\/h2>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p>Any company that plans to conduct clinical trials in Russia should have robust support from a locally based regulatory team that has a deep understanding of the requirements and is aware of any regulatory changes.<\/p><\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Documents for authorization of Clinical Trials<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">Application letter<\/span><\/li><li><span data-preserver-spaces=\"true\">Proof of payment of state duty<\/span><\/li><li><span data-preserver-spaces=\"true\">Report on preclinical trials of the medicinal product and report on earlier clinical trials of the investigational drug (if any).<\/span><\/li><li><span data-preserver-spaces=\"true\">Clinical trial protocol<\/span><\/li><li><span data-preserver-spaces=\"true\">Investigator&#8217;s Brochure<\/span><\/li><li><span data-preserver-spaces=\"true\">Informed consent form and information sheets of the patients<\/span><\/li><li><span data-preserver-spaces=\"true\">Data about the investigators\u2019 work experience in the relevant specializations and their clinical trial experience<\/span><\/li><li><span data-preserver-spaces=\"true\">Information about health care institution, where the clinical trial is to be conducted<\/span><\/li><li><span data-preserver-spaces=\"true\">Information about proposed timelines for the clinical trial<\/span><\/li><li><span data-preserver-spaces=\"true\">Copies of policies for compulsory life and medical insurance of patients to be enrolled in the clinical trials<\/span><\/li><li><span data-preserver-spaces=\"true\">Information about the composition of the investigational product<\/span><\/li><li><span data-preserver-spaces=\"true\">A document by the manufacturer providing data about the characteristics (parameters) of the investigational product manufactured for the clinical trial.<\/span><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Requirements for Institutions doing CTs<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>Accreditation by MoH License for medical activity<\/li><li>Intensive care unit if phase I studies are planned<\/li><li>Presence of copies of legislative documents regarding CTs<\/li><li>Compliance with GCP<\/li><li>Protection of confidential information<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Requirements for investigators<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>5-years experience in clinical trials as a PI<\/li><li>Specialization is relevant to the field of the trial<\/li><li>Submitted CV (template is available) should contain the following <ul><li>Information about CT experience:<\/li><li>Protocol ID and title in Russian, phase, timelines<\/li><li>Number of regulatory approval of the CT<\/li><li>PI\u2019s name if the applicant was a co-investigator<\/li><li>Document proving participation in the study as co-investigator <\/li><\/ul><\/li><li>Registry of investigators will be available in the Internet<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Electronic application requirements<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>Detailed application form on the website of MoH (http:\/\/grls.rosminzdrav.ru\/registrate.aspx)<\/li><li>All submitted documents should be attached<\/li><li>Electronic application duplicates the paper one<\/li><li>Currently, the electronic application is requested before the final stage of approval<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Ethics Committee<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>There are two levels of ECs in Russia, federal level (central level) and local\/institutional.<\/li><li>The sponsor is responsible for submitting the request for the expert ethical opinion to the &#8216;Council on Ethics&#8217;, a subordinated organization within the Ministry of Health and Social Development, as part of the application for the clinical trial permit.<\/li><li>The principal investigator is responsible for submitting the request to the local (institutional affiliated) research ethics committee. [6]<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Process of approval<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">The process starts with compiling all the required documents and submitting them to (MOH) Ministry of Health Care and Social Development.<\/span><\/li><li><span data-preserver-spaces=\"true\">The Department of State Regulation of Drug Circulation checks the submitted documents for completeness and issues a written acceptance notification to the applicant within 5 working days.<\/span><\/li><li><span data-preserver-spaces=\"true\">The study application after a review of the completeness of the submission is forwarded to NEC (National Ethics Council) &amp; (SCEMP) Scientific Center of Expertise of Medicines and Medical Devices or return if the application is lacking details or incomplete<\/span><\/li><li><span data-preserver-spaces=\"true\">Both subordinated organizations review the documents<\/span><\/li><li><span data-preserver-spaces=\"true\">Ethics Council (NEC) gives its opinion on the approval\/rejection, and<\/span><\/li><li><span data-preserver-spaces=\"true\">Expert Organization (SCEMP) provides its expert inputs sourced from experts in CMC, toxicology, pharmacology, clinicians, etc.<\/span><\/li><li><span data-preserver-spaces=\"true\">At the federal level, the ethics &amp; expert review is to be completed within 35 days (which is hardly ever met actually, and even timelines of 75-120 days have been reported).<\/span><\/li><li><span data-preserver-spaces=\"true\">If the application is approved by the concerned bodies, it is forwarded to the Ministry of Health Care and Social Development.<\/span><\/li><li><span data-preserver-spaces=\"true\">An approved study is informed to the applicant. [5][6]<\/span><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><figure><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-930\" src=\"https:\/\/credevo.com\/articles\/\/wp-content\/uploads\/2018\/12\/Russia_regulatory_Appoval_process-300x211.png\" alt=\"\" width=\"674\" height=\"474\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_regulatory_Appoval_process-300x211.png 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2018\/12\/Russia_regulatory_Appoval_process.png 676w\" sizes=\"(max-width: 674px) 100vw, 674px\" \/><\/figure><\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Approval timeline<\/h2>\n\n\n\n<p>The approximate approval timeline is 2 -4 months depending on the case.<\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Do you need any support for your clinical trial in Russia?<\/h2>\n\n\n\n<p>Provide your requirement details below to connect with us and explore our clinical development, monitoring, and regulatory support in Russia<\/p>\n\n\n<div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-940\"><form id=\"wpforms-form-940\" class=\"wpforms-validate wpforms-form\" data-formid=\"940\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/articles\/wp-json\/wp\/v2\/posts\/923\" data-token=\"0c416f2983379bba41635c56e32a341e\" data-token-time=\"1776938154\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-940-field_5-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"5\"><label class=\"wpforms-field-label\" for=\"wpforms-940-field_5\">Provide your requirements details below <span class=\"wpforms-required-label\">*<\/span><\/label><textarea id=\"wpforms-940-field_5\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][5]\" required><\/textarea><\/div><div 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name=\"g-recaptcha-hidden\" class=\"wpforms-recaptcha-hidden\" style=\"position:absolute!important;clip:rect(0,0,0,0)!important;height:1px!important;width:1px!important;border:0!important;overflow:hidden!important;padding:0!important;margin:0!important;\" data-rule-recaptcha=\"1\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"940\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/credevo.com\/articles\/wp-json\/wp\/v2\/posts\/923\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-940\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><\/div><\/form><\/div>  <!-- .wpforms-container -->\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">References<\/h3>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"http:\/\/www.biorasi.com\/assests\/white-papers\/Biorasi%20-%20Navigating%20through%20the%20Clinical%20Trial%20Authorization%20Process%20in%20Russia-v0-1.pdf\">http:\/\/www.biorasi.com\/assests\/white-papers\/Biorasi%20-%20Navigating%20through%20the%20Clinical%20Trial%20Authorization%20Process%20in%20Russia-v0-1.pdf<\/a><\/li><li><a href=\"http:\/\/www.jforcs.com\/wp-content\/uploads\/2017\/02\/Clinical-trials.pdf\">http:\/\/www.jforcs.com\/wp-content\/uploads\/2017\/02\/Clinical-trials.pdf<\/a><\/li><li><a href=\"http:\/\/www.fisherclinicalservices.com\/en\/learning-center\/insights-blog-overview\/7-best-practices-in-bringing-a-clinical-trial-to-russia.html\">http:\/\/www.fisherclinicalservices.com\/en\/learning-center\/insights-blog-overview\/7-best-practices-in bringing-a-clinical-trial-to-russia.html<\/a><\/li><li><a href=\"https:\/\/premier-research.com\/wp-content\/uploads\/2014\/12\/Experience_Russia_201206.pdf\">https:\/\/premier-research.com\/wp-content\/uploads\/2014\/12\/Experience_Russia_201206.pdf<\/a><\/li><li><a href=\"https:\/\/clinicaltrialsarena.com\/news\/clinical-trials-arena\/exploring-considerations-to-help-carry-out-clinical-trials-in-russia-5709878-2\/\">https:\/\/clinicaltrialsarena.com\/news\/clinical-trials-arena\/exploring-considerations-to-help-carry-out-clinical-trials-in-russia-5709878-2\/<\/a><\/li><li><a href=\"https:\/\/www.nihcollaboratory.org\/sites\/CbyC\/Pages\/SnapshotDrug.aspx\">https:\/\/www.nihcollaboratory.org\/sites\/CbyC\/Pages\/SnapshotDrug.aspx<\/a><\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Russia has become an increasingly attractive venue for conducting clinical trials for international pharmaceutical companies. Russian clinics and principal investigators have proven to be highly capable of conducting clinical research at a level of quality not less than that of investigators in Western Europe and North America. Clinical trials in Russia Sponsors are considering Russia [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":924,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"cybocfi_hide_featured_image":"","footnotes":""},"categories":[566,4],"tags":[267,553,93,138],"class_list":["post-923","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-development","category-regulatory","tag-clinical-trial","tag-mhcsd","tag-moh","tag-russia"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Russia - Clinical Trial Regulatory Process | Credevo Articles<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/credevo.com\/articles\/2018\/07\/30\/russia-clinical-trial-regulatory-process\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Russia - Clinical Trial Regulatory Process | Credevo Articles\" \/>\n<meta property=\"og:description\" content=\"Russia has become an increasingly attractive venue for conducting clinical trials for international pharmaceutical companies. 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