{"id":171,"date":"2017-02-14T22:35:14","date_gmt":"2017-02-14T14:35:14","guid":{"rendered":"https:\/\/credevo.com\/articles\/\/?p=171"},"modified":"2024-10-12T14:56:36","modified_gmt":"2024-10-12T06:56:36","slug":"update-1-thailands-clinical-trial-regulatory-scenario","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2017\/02\/14\/update-1-thailands-clinical-trial-regulatory-scenario\/","title":{"rendered":"Thailand Clinical Trial Regulatory Scenario: Update 1"},"content":{"rendered":"\n<p>Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)\/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications.<\/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\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-1024x548.jpg\" alt=\"Clinical trial regulatory in Vietnam\" class=\"wp-image-3655\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-1024x548.jpg 1024w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-300x161.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-768x411.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-732x392.jpg 732w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo-1140x610.jpg 1140w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/10\/Thailand_IRB_Ethicscommittee_clinical_trial_approval_update1_credevo.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>In our previous articles (see&nbsp;<a href=\"https:\/\/credevo.com\/articles\/\/2016\/09\/12\/thailands-clinical-trial-regulatory-scenario-simplified-12\/\">Part I<\/a>&nbsp;and&nbsp;<a href=\"https:\/\/credevo.com\/articles\/\/2016\/09\/26\/thailands-clinical-trial-regulatory-scenario-simplified-22\/\">Part II<\/a>), we\u2019ve discussed the regulatory scenario in Thailand, including <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>regulatory approvals for the clinical trial in Thailand,<\/li>\n\n\n\n<li>ethics committee approval for the clinical trial in Thailand,<\/li>\n\n\n\n<li>documents required for regulatory submission, and<\/li>\n\n\n\n<li>ethics committee submission in Thailand.<\/li>\n<\/ul>\n\n\n\n<p>We\u2019ve also presented a list of ethics committees that are recognized for application to the Thailand FDA.<\/p>\n\n\n\n<p><span style=\"font-size: inherit;\">The Thai FDA has updated the list of currently recognized ethics committees in Thailand in the revised notification.<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">List of Ethics Committees recognized by Thailand FDA<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>#<\/strong><\/td><td><strong>Name of IRB, or name of institute \/ Hospital \/ University, where IRB is established<\/strong><\/td><td><strong>Recognition starts from<\/strong><\/td><td><strong>Recognition end on<\/strong><\/td><\/tr><tr><td>1.<\/td><td>Bangkok Hospital, Bangkok<\/td><td>07 Oct 2016<\/td><td>06 Oct 2018<\/td><\/tr><tr><td>2<\/td><td>Phramongkutklao College of Medicine, Bangkok<\/td><td>05 Oct 2016<\/td><td>04 Oct 2018<\/td><\/tr><tr><td>3.<\/td><td>IHRP, Bangkok<\/td><td>07 Oct 2016<\/td><td>06 Oct 2018<\/td><\/tr><tr><td>4.<\/td><td>Bumrungrad Hospital, Bangkok<\/td><td>07 Oct 2016<\/td><td>06 Oct 2018<\/td><\/tr><tr><td>5.<\/td><td>Khon Kaen University, Khon Kaen<\/td><td>11 Nov 2016<\/td><td>10 Nov 2018<\/td><\/tr><tr><td>6.<\/td><td>Siriraj Hospital, Mahidol University, Bangkok<\/td><td>24 Nov 2016<\/td><td>23 Nov 2018<\/td><\/tr><tr><td>7.<\/td><td>Mahidol University\u2019s Center of Ethical Reinforcement for Human Research, Bangkok<\/td><td>29 Nov 2016<\/td><td>28 Nov 2018<\/td><\/tr><tr><td>8.<\/td><td>Ramathibodhi Hospital, Bangkok<\/td><td>07 Dec 2016<\/td><td>06 Dec 2018<\/td><\/tr><tr><td>9.<\/td><td>MOPH IRB, Bangkok<\/td><td>06 Dec 2016<\/td><td>05 Dec 2018<\/td><\/tr><tr><td>10.<\/td><td>CREC, Bangkok<\/td><td>07 Dec 2016<\/td><td>06 Dec 2018<\/td><\/tr><tr><td>11.<\/td><td>Naresuan University, Pitsanulok<\/td><td>10 Apr 2015<\/td><td>09 Apr 2017<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Important modifications in the new list<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Thailand FDA revises the list of IECs \/ IRBs almost every two years, and this time revision is of greater significance. Let\u2019s see why it is so.<\/li>\n\n\n\n<li>The Thai FDA recognized ethics committees (ECs) from private hospitals for the first time.<\/li>\n\n\n\n<li>Two such private hospitals\u2019 ECs are namely Bangkok Hospital and Bumrungrad Hospital.<\/li>\n\n\n\n<li>Thai FDA, in the new list, skipped the big university hospitals like Chiang Mai University, Prince of Hat Yai University Songkhla, and Chulalongkorn University.<\/li>\n\n\n\n<li>Govt. IECs\/IRBs like the MOPH ethics committee and the new one on the bloc \u2013 CREC are continuing. Read more about CREC in our\u00a0<a href=\"https:\/\/credevo.com\/articles\/\/2016\/09\/12\/thailands-clinical-trial-regulatory-scenario-simplified-12\/\" target=\"_blank\" rel=\"noreferrer noopener\">previous post<\/a>.<\/li>\n\n\n\n<li>The list includes IHRP this time as well however, currently, no new applications are being accepted there, as reported by some of our industry contacts.<\/li>\n\n\n\n<li>Naresuan University, present in the last modification, continues to be approved until 9 Apr 2017. Thai FDA may decide its further continuation in this list later on.<\/li>\n\n\n\n<li>University and Govt. hospitals\/sites, continuing in the recognized ECs list, include Siriraj Hospital, Khon Khaen University, PMK (armed forces\u2019 hospital), Ramathiodhi Hospital, and Faculty of Tropical Medicine, Mahidol University.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity is-style-wide\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Need support for conducting your clinical trials in Thailand?<\/h2>\n\n\n\n<p>Credevo offers expertise in drug product registration, clinical trial regulations, and many more services in Thailand. Fill in the details of your requirements in the <a href=\"#form\">form below<\/a> to connect with us.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity is-style-wide\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Impact of a new list of recognized ECs<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Private hospitals<\/h3>\n\n\n\n<p><span style=\"font-size: inherit;\">There is no doubt that some trial management teams find it more convenient if their clinical sites are at private hospitals. Decision-making is faster, clinical investigators can be more approachable, many institution-related works can be finished quickly, or find the staff more professional.<\/span><\/p>\n\n\n\n<p>The inclusion of Bangkok Hospital and Bumrungrad Hospital in this list opens new avenues for trial planners and site selection teams. Both are very experienced, well-equipped, and professional sites capable of handling large trials.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Central Research Ethics Committees (CREC)<\/h3>\n\n\n\n<p><span style=\"font-size: inherit;\">As discussed in our&nbsp;<\/span><a style=\"font-size: inherit;\" href=\"https:\/\/credevo.com\/articles\/\/2016\/09\/12\/thailands-clinical-trial-regulatory-scenario-simplified-12\/\">previous article<\/a><span style=\"font-size: inherit;\">, this new central ethics committee is one of the best things that happened to the <\/span>Thailand clinical trial scene in the last few years. It\u2019s recognized by FDA, affiliated to several sites in Thailand, and still not heavily loaded with clinical trial applications.&nbsp;It means shorter queues for submission, quicker approval times, and, best of all, flexibility to work at several excellent sites in Thailand. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Saving time\u2026and cost!<\/h3>\n\n\n\n<p>If a site is not an affiliate of a Thai FDA-recognized EC, the investigator needs to apply to two ECs for approval, Local EC and Central EC (recognized by the FDA). In such cases, there may be a delay in project approval due to the submission queue at the central EC office. It means one needs to consider an additional 3-9 months for planning.<\/p>\n\n\n\n<p>The sponsor can save a lot of time securing necessary EC approval if a sponsor plans a clinical trial at an FDA-recognized EC affiliate site. The sponsor can also save the cost of planning, execution, and management.<\/p>\n\n\n\n<p>Trial managers do factor these sites into your project planning. \ud83d\ude42<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to benefit from these developments?<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Start exploring Thailand for clinical trials<\/h3>\n\n\n\n<p><span style=\"font-size: inherit;\">If you\u2019ve not done so, this is a good time to start your clinical trials in Thailand. There is an increased awareness about supporting clinical trials by the Govt. authorities.<\/span> <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Explore new clinical sites as well<\/h3>\n\n\n\n<p><span style=\"font-size: inherit;\">Thailand is a very good option to place your clinical trial if it\u2019s a global clinical trial or one intended to be submitted to the Thailand FDA. It\u2019s the country with the highest number of clinical trials in the ASEAN region.<\/span><\/p>\n\n\n\n<p>There are plenty of potential investigators, trained sites, and a very mature awareness of global clinical trial systems and regulations. Although some sites (like Siriraj Hospitals, Ramathobodhi Hospital, etc) are quite famous (and, very busy too), trial managers can (and should) explore other options as well.<\/p>\n\n\n\n<p><span style=\"font-size: inherit;\">Try exploring clinical trial feasibility with investigators in Thailand. You can do so easily with&nbsp;<\/span><a style=\"font-size: inherit;\" href=\"http:\/\/credevo.com\">Credevo<\/a><span style=\"font-size: inherit;\">. To do so,&nbsp;<\/span><a style=\"font-size: inherit;\" href=\"http:\/\/credevo.com\/myzone\/project_submit\">post your project with preliminary details<\/a><span style=\"font-size: inherit;\">.<\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Connect with Thailand consultants<\/h3>\n\n\n\n<p><span style=\"font-size: inherit;\">You can make the most of these advantages if you have a trial team based in Thailand. If you don\u2019t have it yet, you can still explore Thailand with the help of several consultants. These consultants are industry experts\/veterans, who have worked in various capacities in the pharma \/ clinical research industry.<\/span> <\/p>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"form\">Do you need any clinical development or regulatory support in Thailand?<\/h2>\n\n\n\n<p>Provide your required details below to talk with us.<\/p>\n\n\n<div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-1355\"><form id=\"wpforms-form-1355\" class=\"wpforms-validate wpforms-form\" data-formid=\"1355\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/articles\/wp-json\/wp\/v2\/posts\/171\" data-token=\"78ebd23c307aedcdf5faebd39bb555ea\" data-token-time=\"1775603060\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-1355-field_7-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"7\"><label class=\"wpforms-field-label\" for=\"wpforms-1355-field_7\">Provide your query here !<\/label><textarea id=\"wpforms-1355-field_7\" class=\"wpforms-field-medium\" name=\"wpforms[fields][7]\" ><\/textarea><\/div><div id=\"wpforms-1355-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label\" for=\"wpforms-1355-field_1\">Your work email <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"email\" id=\"wpforms-1355-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-1355-field-hp\" class=\"wpforms-field-label\">Message<\/label><input type=\"text\" name=\"wpforms[hp]\" id=\"wpforms-1355-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=\"1355\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/credevo.com\/articles\/wp-json\/wp\/v2\/posts\/171\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-1355\" 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 has-css-opacity\"\/>\n\n\n\n<h4 class=\"wp-block-heading\">Want to know more click the following links<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/credevo.com\/articles\/2017\/02\/14\/update-1-thailands-clinical-trial-regulatory-scenario\/\">Latest updates on Clinical Trial Regulatory Scenario in Thailand<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/credevo.com\/articles\/2019\/03\/27\/update-2-thailands-latest-approved-irb-list\/\">Thailand\u2019s Latest Approved IRB List<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/credevo.com\/articles\/2018\/09\/30\/marketing-authorization-regulatory-requirements-for-drug-registration-in-thailand\/\">Marketing Authorization &amp; Regulatory Requirements for Drug Registration in Thailand<\/a> <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)\/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications. In our previous articles (see&nbsp;Part I&nbsp;and&nbsp;Part II), we\u2019ve discussed the regulatory scenario in Thailand, including We\u2019ve also presented a list of ethics committees that are recognized for application to the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":3655,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"cybocfi_hide_featured_image":"","footnotes":""},"categories":[566,4],"tags":[267,558,36],"class_list":["post-171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-development","category-regulatory","tag-clinical-trial","tag-tfda","tag-thailand"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Clinical Trial Regulatory Scenario &amp; Approval in Thailand | Credevo Articles<\/title>\n<meta name=\"description\" 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