{"id":350,"date":"2017-07-31T19:00:59","date_gmt":"2017-07-31T11:00:59","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=350"},"modified":"2021-09-21T15:29:18","modified_gmt":"2021-09-21T07:29:18","slug":"poland-clinical-trial-advantages-and-regulatory-process","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2017\/07\/31\/poland-clinical-trial-advantages-and-regulatory-process\/","title":{"rendered":"Poland &#8211; Clinical Trial Advantages And Regulatory Process"},"content":{"rendered":"\n<p><strong>Poland<\/strong>&nbsp;is regarded as one of the largest clinical trials markets in CEE\/CIS. <span data-preserver-spaces=\"true\">In a report in 2010, PriceWaterhouseCoopers (PwC) pointed out that with 469 new clinical trial registrations in 2009, Poland accounted for c. 2.5%-3.0% of the world market by registration volumes.<\/span><\/p>\n\n\n\n<figure class=\"wp-block-image\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"548\" src=\"https:\/\/credevo.com\/articles\/\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-1024x548.jpg\" alt=\"Poland_clinical_trial_advantages_regulatory_process_credevo\" class=\"wp-image-355\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-1024x548.jpg 1024w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-300x161.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-768x411.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-732x392.jpg 732w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo-1140x610.jpg 1140w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Poland_clinical_trial_advantages_regulatory_process_credevo.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Current status of clinical research in Poland<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">The status of clinical research has degraded over the years in Poland. In a subsequent report in 2015, the same agency (PwC) indicated that Poland\u2019s clinical trials market has been stagnant in recent years.<\/span><\/li><li><span data-preserver-spaces=\"true\">Between 2012 and 2014, there was a drop in the number of new clinical trial registrations, which can be attributed to a number of both local and global factors. One of these factors was reported as lengthy administrative procedures and a large number of formal requirements in Poland.<\/span><\/li><\/ul>\n\n\n\n<p><span data-preserver-spaces=\"true\">Despite these requirements, Poland carries certain advantages in clinical trial conducts that are hard to ignore.<\/span><\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<blockquote class=\"wp-block-quote is-style-large 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><\/p><\/blockquote>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Why Poland still is a good clinical trial site?<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Large population of patients<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">Poland has a relatively large population in comparison with neighboring countries.<\/span><\/li><li><span data-preserver-spaces=\"true\">Moreover, there seems to be a greater motivation for patients in Poland to become involved in clinical trials, compared to mature Western European markets.<\/span><\/li><li><span data-preserver-spaces=\"true\">This is because patients participating in trials in Poland usually have access to medical treatment of a higher level than is the case of standard care.<\/span><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Specialized medical centers<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">There are a considerable number of specialized medical centers clustered around main cities (e.g. Warszawa, Wroc\u0142aw, Krak\u00f3w, Pozna\u0144, Szczecin, Gda\u0144sk, Lublin, Bydgoszcz, Rzesz\u00f3w).<\/span><\/li><li><span data-preserver-spaces=\"true\">These centers have well-qualified specialists and provide access to patients in all therapeutic areas, particularly oncology, rheumatology, cardiology, and pediatrics.<\/span><\/li><li><span data-preserver-spaces=\"true\">As per the report (referenced from the Polish Central Statistical Office GUS report ) in 2014 indicates the number of hospitals and healthcare facilities as more than 800 hospitals and 16,600 outpatient facilities.<\/span><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Highly interested, qualified and motivated investigators and site staff<\/h3>\n\n\n\n<p>Polish investigators are generally highly motivated to conduct clinical trials, as they can see the benefits in the work they do more than their colleagues in Western countries. Clinical trials are attractive to investigators because of<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Possibility to test new treatment standards,<\/li><li>Exchange information with foreign experts,<\/li><li>Financial benefits, and<\/li><li>Opportunity to have co-authored publications in respected branch magazines.<\/li><\/ol>\n\n\n\n<p>General rich experience of over 20 years is well reflected in the quality of clinical research data from Poland provided by investigators and site staff.<\/p>\n\n\n\n<p><strong>It is worth noting that no Polish investigator is present on the FDA\u2019s list of disqualified investigators.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Relatively low costs<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">Poland holds a strategic advantage in having a much lower cost of conducting clinical trials (nearly 30% less) than in the U.S.<\/span><\/li><li><span data-preserver-spaces=\"true\">This is due to a high rate of patient recruitment and excellent quality of data, leading to a reduced number of rejected clinical trial recordings and time-efficient proceedings.<\/span><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Top challenges with clinical trials in Poland<\/h2>\n\n\n\n<p><span data-preserver-spaces=\"true\">However, there are some key challenges for the Polish clinical trial market, which concerns some companies. These challenges include<\/span><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">A regulatory process requiring the signing of clinical trial agreements first<\/span><\/li><li><span data-preserver-spaces=\"true\">Administrative procedures regarding the signing of a clinical trial agreement at different sites may differ with the type of the site.<\/span><\/li><\/ol>\n\n\n\n<p><span data-preserver-spaces=\"true\">To overcome these challenges and utilize the above-mentioned advantages, it helps to understand the clinical trial regulatory process and expected timelines.<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical trial regulations &amp; processes in Poland<\/h2>\n\n\n\n<p>Like many other countries, Poland has 3 different approvals required generally.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Regulatory authority (RA)<\/li><li>Ethics Committee (EC), and<\/li><li>Import license<\/li><\/ol>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img loading=\"lazy\" decoding=\"async\" width=\"967\" height=\"725\" src=\"https:\/\/credevo.com\/articles\/\/wp-content\/uploads\/2017\/11\/Clinical_trial_process_Poland_credevo.jpg\" alt=\"Clinical_trial_process_Poland_credevo\" class=\"wp-image-356\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Clinical_trial_process_Poland_credevo.jpg 967w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Clinical_trial_process_Poland_credevo-300x225.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Clinical_trial_process_Poland_credevo-768x576.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/Clinical_trial_process_Poland_credevo-732x549.jpg 732w\" sizes=\"(max-width: 967px) 100vw, 967px\" \/><\/figure><\/div>\n\n\n\n<p class=\"has-text-align-center has-small-font-size\"><strong><em>Figure 1: Clinical Trial Regulatory Process in Poland<\/em><\/strong><\/p>\n\n\n\n<p>Submissions to RA &amp; EC differ as per the type of sponsor and investigational agent.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its authorized representative.<\/li><li>Before the CTA is filed to the RA and EC, all non-EU sponsors must appoint a so-called \u2018Legal Representative\u2019 that has to be legally established in the European Union.<\/li><li>Application for drug studies can be made to RA and EC in parallel, however, the CTA for medical devices must be made to the RA after EC approval has been obtained.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Regulatory Agency (RA)<\/h3>\n\n\n\n<p><span data-preserver-spaces=\"true\">The sponsor must apply for authorization to conduct a clinical trial on an investigational agent (IMP) to the competent authority in Poland, which is the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, one department of which is responsible for GCP assessment and maintains the Central Register of Clinical Trials.<\/span><\/p>\n\n\n\n<p><span data-preserver-spaces=\"true\">When applying to RA, the sponsor or their representative must submit the following documents.<\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Documents<\/h3>\n\n\n\n<figure class=\"wp-block-image\"><img loading=\"lazy\" decoding=\"async\" width=\"960\" height=\"720\" src=\"https:\/\/credevo.com\/articles\/\/wp-content\/uploads\/2017\/11\/CTA_documents_RA_Poland_Credevo-1.jpg\" alt=\"CTA_documents_RA_Poland_Credevo\" class=\"wp-image-361\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/CTA_documents_RA_Poland_Credevo-1.jpg 960w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/CTA_documents_RA_Poland_Credevo-1-300x225.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/CTA_documents_RA_Poland_Credevo-1-768x576.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2017\/11\/CTA_documents_RA_Poland_Credevo-1-732x549.jpg 732w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-center has-small-font-size\"><strong><em>Figure 2: Documents to be submitted for the clinical trial application to RA in Poland<\/em><\/strong><\/p>\n\n\n\n<p>Some additional but important notes.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">The CTA approval process is 60 days long.<\/span><\/li><li><span data-preserver-spaces=\"true\">RA requires that the contracts for all participating sites in Poland must be signed and submitted to RA before the CTA submission (medical device studies) or between the CTA submission and the end of the 60-day period of the CTA approval process (drug studies).<\/span><\/li><li><span data-preserver-spaces=\"true\">To expedite the process in large studies, the initial request may be made for a reduced number of sites.<\/span><\/li><li><span data-preserver-spaces=\"true\">Following the initial RA approval and when the site-specific documents, including signed contracts for the remaining sites, are ready for submission, the request may be amended to add these clinical sites.<\/span><\/li><li><span data-preserver-spaces=\"true\">The review and approval of additional sites by the RA can take up to 35 days.<\/span><\/li><\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">Ethics Committee (EC)<\/h3>\n\n\n\n<p><span data-preserver-spaces=\"true\">Salient points for submission of documents and process of EC approvals for clinical trials in Poland<\/span><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">From all Principal Investigators participating in the study in Poland, a Country Coordinator must be chosen and his\/her local EC becomes the Central EC (CEC) responsible for review and approval of the whole study.<\/span><\/li><li><span data-preserver-spaces=\"true\">The CEC issues the single opinion on the clinical trial and directly informs about the study of the local ECs of all participating Principal Investigators.<\/span><\/li><li><span data-preserver-spaces=\"true\">The local EC then within 2 weeks is responsible for giving an opinion on the investigator and the site facilities.<\/span><\/li><li><span data-preserver-spaces=\"true\">If the local ECs will give favorable opinions about the sites or will not respond during the mentioned above timelines, the study is considered approved for all sites submitted within the application.<\/span><\/li><li><span data-preserver-spaces=\"true\">The law forbids payment to patients for taking part in a clinical trial, other than their traveling expenses.<\/span><\/li><li><span data-preserver-spaces=\"true\">Loss of earnings might be included in the lump sum.<\/span><\/li><li><span data-preserver-spaces=\"true\">Payment may be made to healthy volunteers taking part in bioavailability studies, or Phase I studies conducted in Poland. But, payment for \u201csick\u201d volunteers is forbidden.<\/span><\/li><li><span data-preserver-spaces=\"true\">The period of EC approval is generally 40-45 days in Poland.<\/span><\/li><\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">IMP clinical trials<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><span data-preserver-spaces=\"true\">If the study drug or the medical device will be imported from an EU country, there is no need for an import license.<\/span><\/li><li><span data-preserver-spaces=\"true\">However, if the import will be done from a non-EU country, then an import license is required from the RA.<\/span><\/li><li><span data-preserver-spaces=\"true\">The quantity of the study drug or medical device to be used in the study must be specified \u2013 as per standard practice, a surplus of 25 % may be included in the request to ensure the sufficient number of study supplies are imported to Poland.<\/span><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical trial sites &amp; investigators in Poland<\/h2>\n\n\n\n<p>With high levels of subject recruitment, high data quality and committed investigators, and relatively low costs, Poland is an attractive location for clinical research.<\/p>\n\n\n\n<p>These advantages, clear knowledge of regulatory requirements, and quick connectivity with sites and investigators in Poland can ensure a smooth, quick, and cost-effective execution of clinical trials.<\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Need Support for conducting your clinical trials in Poland or Have questions?<\/h2>\n\n\n\n<p>We&#8217;d love to help you conduct clinical trials in Poland.<\/p>\n\n\n\n<p>Provide your details below.<\/p>\n\n\n<div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-2848\"><form id=\"wpforms-form-2848\" class=\"wpforms-validate wpforms-form\" data-formid=\"2848\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/articles\/wp-json\/wp\/v2\/posts\/350\" data-token=\"add4d557579c499176b2118a5a7b9036\" data-token-time=\"1778683987\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-2848-field_6-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"6\"><label class=\"wpforms-field-label\" for=\"wpforms-2848-field_6\">What kind of support do you need in Poland? <span class=\"wpforms-required-label\">*<\/span><\/label><textarea id=\"wpforms-2848-field_6\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][6]\" required><\/textarea><\/div><div id=\"wpforms-2848-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label\" for=\"wpforms-2848-field_1\">What is your work email? <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"email\" id=\"wpforms-2848-field_1\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][1]\" spellcheck=\"false\" required><div class=\"wpforms-field-description\">Provide your work email, where we can contact you<\/div><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-field wpforms-field-hp\"><label for=\"wpforms-2848-field-hp\" class=\"wpforms-field-label\">Comment<\/label><input type=\"text\" name=\"wpforms[hp]\" id=\"wpforms-2848-field-hp\" class=\"wpforms-field-medium\"><\/div><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v2\" ><div class=\"g-recaptcha\" data-sitekey=\"6LeaQRYTAAAAAPo7U8jnZJBUndxcS3f0E3Vijb2k\"><\/div><input type=\"text\" 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=\"2848\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/credevo.com\/articles\/wp-json\/wp\/v2\/posts\/350\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2848\" 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=\"https:\/\/www.pwc.com\/gx\/en\/pharma-life-sciences\/assets\/clinical-trials-in-poland-2010.pdf\">https:\/\/www.pwc.com\/gx\/en\/pharma-life-sciences\/assets\/clinical-trials-in-poland-2010.pdf<\/a><\/li><li><a href=\"https:\/\/www.gcppl.org.pl\/Portals\/2\/reports\/Clinical-Trials-in-Poland_12-2015_FINAL.pdf\">https:\/\/www.gcppl.org.pl\/Portals\/2\/reports\/Clinical-Trials-in-Poland_12-2015_FINAL.pdf<\/a><\/li><li><a href=\"http:\/\/cropoland.com\/requirements.html\">http:\/\/cropoland.com\/requirements.html<\/a><\/li><li><a href=\"https:\/\/www.cromsource.com\/wp-content\/uploads\/2012\/12\/Clinical-Trials-in-Poland.pdf\">https:\/\/www.cromsource.com\/wp-content\/uploads\/2012\/12\/Clinical-Trials-in-Poland.pdf<\/a><\/li><li><a href=\"http:\/\/www.urpl.gov.pl\">http:\/\/www.urpl.gov.pl<\/a><\/li><li><a href=\"http:\/\/www.nil.org.pl\/\">http:\/\/www.nil.org.pl\/<\/a><\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Poland&nbsp;is regarded as one of the largest clinical trials markets in CEE\/CIS. In a report in 2010, PriceWaterhouseCoopers (PwC) pointed out that with 469 new clinical trial registrations in 2009, Poland accounted for c. 2.5%-3.0% of the world market by registration volumes. Current status of clinical research in Poland The status of clinical research has [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":355,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"cybocfi_hide_featured_image":"","footnotes":""},"categories":[566,4],"tags":[267,66,595],"class_list":["post-350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-development","category-regulatory","tag-clinical-trial","tag-poland","tag-ra"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Poland - Clinical Trial Advantages And 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\/2017\/07\/31\/poland-clinical-trial-advantages-and-regulatory-process\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Poland - Clinical Trial Advantages And Regulatory Process | Credevo Articles\" \/>\n<meta property=\"og:description\" content=\"Poland&nbsp;is regarded as one of the largest clinical trials markets in CEE\/CIS. In a report in 2010, PriceWaterhouseCoopers (PwC) pointed out that with 469 new clinical trial registrations in 2009, Poland accounted for c. 2.5%-3.0% of the world market by registration volumes. 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