{"id":4089,"date":"2020-11-25T11:19:15","date_gmt":"2020-11-25T03:19:15","guid":{"rendered":"https:\/\/credevo.com\/articles\/?p=4089"},"modified":"2022-09-06T16:17:54","modified_gmt":"2022-09-06T08:17:54","slug":"clinical-ancillary-supplies-import-into-japan","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2020\/11\/25\/clinical-ancillary-supplies-import-into-japan\/","title":{"rendered":"Importation Of Clinical Trial Ancillary Supplies Into Japan"},"content":{"rendered":"\n<p>The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of these clinical trial ancillary supply products in advance.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><em><strong>Note: This article was last updated in September 2022<\/strong><\/em>.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-1024x576.jpg\" alt=\"Import of clinical ancillary supply into Japan for clinical trials\" class=\"wp-image-4093\" srcset=\"https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-1024x576.jpg 1024w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-300x169.jpg 300w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-768x432.jpg 768w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-1536x864.jpg 1536w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-732x412.jpg 732w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo-1140x641.jpg 1140w, https:\/\/credevo.com\/articles\/wp-content\/uploads\/2020\/12\/Clinical_ancillary_supplies_japan_import_export_Credevo.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<p>In Japan, the process and the regulations for the importation of clinical supplies are slightly different. However, products need to be completely in compliance with Japanese standards.<\/p>\n\n\n\n<p>For the import of clinical trial supplies in Japan, it&#8217;s important to understand the<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Regulations and processes related to the import of clinical ancillary supplies in Japan<\/li><li>Required documents and approvals for seeking approvals for such import<\/li><li>Entities or personnel who can be authorized for import of these products<\/li><li>The role that different factors such as the origin of port and port of import play, and<\/li><li>Cost and timelines for the entire process of import<\/li><\/ol>\n\n\n\n<p>After understanding the requirements, regulations, and process for the import, it&#8217;s time to check different requirements applicable to your specific clinical trial and ancillary supplies.<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"block-3d522b2f-1ae9-4e23-a6dd-f7cf8f8873f2\">Need support for import of clinical ancillary supplies into Japan?<\/h3>\n\n\n\n<p id=\"block-67baf30f-ae85-46ce-b3ec-c487604c57f1\">Credevo offers expertise in clinical trial regulations and many related services in Japan. <a href=\"#check-credevo-services\">Check them out now<\/a>!<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Clinical Trial Notification (CTN)<\/h2>\n\n\n\n<p>In Japan, Clinical Trial Notification (CTN) is the most crucial regulatory approval required to initiate any clinical trial-related process. <a href=\"https:\/\/www.pmda.go.jp\/english\/\" target=\"_blank\" rel=\"noreferrer noopener\">Pharmaceuticals and Medical Devices Agency (PMDA)<\/a>, a Japanese regulatory authority, is responsible for CTN. The sponsor shall submit the following documents as a part of a CTN procedure.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Scientific justification for conducting a clinical trial<\/li><li>Clinical Trial Protocol<\/li><li>An informed consent form&nbsp;<\/li><li>A sample of the case report form<\/li><li>Investigator\u2019s brochure, etc.<\/li><\/ul>\n\n\n\n<p>CTN is also an crucial consideration for import of clinical trial ancillary supplies. As explained in the report referred to above, it can be instrumental in the whole import process.<\/p>\n\n\n\n<p>One can consider the clinical trial approved after 30 days and initiate clinical trial-related activities, including import.<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<blockquote class=\"wp-block-quote has-text-align-center is-layout-flow wp-block-quote-is-layout-flow\"><p><a href=\"https:\/\/credevo.com\/articles\/2018\/08\/16\/japan-clinical-trial-regulatory-process\/\" data-type=\"URL\" data-id=\"https:\/\/credevo.com\/articles\/2018\/08\/16\/japan-clinical-trial-regulatory-process\/\" target=\"_blank\" rel=\"noreferrer noopener\">Click here for more details on clinical trial approval Process in Japan &gt;&gt;<\/a><\/p><\/blockquote>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Who will be the importer for clinical trial ancillaries?<\/h2>\n\n\n\n<p>In Japan, the scenario is somewhat different from other countries, and it will be important to know about <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>In-Country Caretaker (ICC)<\/li><li>Importer of Record (IOR)<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">In-Country Caretaker (ICC)<\/h3>\n\n\n\n<p>An In-Country Caretaker (ICC) can be assigned to handle the clinical trial, right from CTN application to the completion of the study, including the importation process. An In-Country Caretaker can be a local or Japanese entity.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Importer of Record (IOR)<\/h3>\n\n\n\n<p>An Importer of the Record (IOR)&nbsp; is the person or entity who takes ownership of the imported goods at the time of import.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What duties does the ICC\/IOR perform on behalf of the Importer?&nbsp;<\/h3>\n\n\n\n<p>An ICC\/IOR performs the following duties on behalf of the importer as follows<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Checks if the product needs special registrations.<\/li><li>Acts as an importer for customs and tax declaration purposes.<\/li><li>Ensures proper documentation and valuation of all the goods for import.<\/li><li>Takes complete authority over the imported products, etc.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Custom Clearance for the Import of clinical trial ancillary into Japan<\/h2>\n\n\n\n<p>The entire import process for clinical supplies may take approximately 5-14 business days and it depends upon the category to which your ancillary supplies belong.<\/p>\n\n\n\n<p>After the customs clearance, the importer ships the products directly to the site destination or arranges a depot for storage if required.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Depot &amp; packaging for importation<\/h2>\n\n\n\n<p>In Japan, the packaging is required to be in compliance with the Japanese standards when it reaches the site. It should be in an acceptable manner. Also, it is preferable to have a local depot for storage in proper condition before it reaches the site in Japan. An ICC\/IOR can manage this task well before on behalf of a foreign sponsor.<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"check-credevo-services\">Do you need support or have queries on the import of clinical trial ancillary into Japan?<\/h2>\n\n\n\n<p>Credevo offers a wide range of drug development and regulatory services in Japan. Choose one of the following options to connect with us.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-button aligncenter button-hover-1 is-style-default is-style-outline is-style-outline--ef75fc7b860e4a59c43da2b32c0ddfd6\"><a class=\"wp-block-button__link has-vivid-cyan-blue-color has-very-light-gray-background-color has-text-color has-background\" href=\"https:\/\/credevo.com\/articles\/asp-payment-box\/?product_id=4099\">Download Report<\/a><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Get the report on the import of clinical ancillary supplies for clinical trials in Japan.<br><em>Note: This report will be charged @ $1424.<\/em><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-button aligncenter button-hover-1 is-style-default is-style-outline is-style-outline--5532a2c6590f0f32c809b55462f0a8f4\"><a class=\"wp-block-button__link has-vivid-cyan-blue-color has-very-light-gray-background-color has-text-color has-background\" href=\"https:\/\/credevo.com\/articles\/?asp_action=show_pp&amp;product_id=5095\">Ask Credevo Expert<\/a><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Do you have a query? Just ask experts at Credevo. <br><em>Note: &#8220;Ask Credevo Expert&#8221; will be charged @ $50 \/ inquiry. Any inquiry requiring more than 30 min of the expert&#8217;s time will incur additional charges.<\/em><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-button aligncenter button-hover-1 is-style-default is-style-outline spu-open-5123 is-style-outline--3d4b20eefbfa55058c756429bb75824b\"><a class=\"wp-block-button__link has-vivid-cyan-blue-color has-very-light-gray-background-color has-text-color has-background\">Request a Proposal<\/a><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Looking for a quotation? Just provide relevant info and we will send you the details.<\/p>\n<\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\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.j-mdc.com\/en\/import\/index.php\">https:\/\/www.j-mdc.com\/en\/import\/index.php<\/a><\/li><li><a href=\"https:\/\/ecommdo.com\/importer-of-record-for-amazon-japan\/\">https:\/\/ecommdo.com\/importer-of-record-for-amazon-japan\/<\/a>&nbsp;<\/li><li><a href=\"https:\/\/www.j-mdc.com\/en\/import\/index.php\">https:\/\/www.j-mdc.com\/en\/import\/index.php<\/a><\/li><li><a href=\"https:\/\/www.customs.go.jp\/english\/\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.customs.go.jp\/english\/<\/a> <\/li><li><a href=\"https:\/\/www.customs.go.jp\/english\/exp-imp\/privatecargo\/private.htm\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.customs.go.jp\/english\/exp-imp\/privatecargo\/private.htm<\/a><\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"<p>The conduct of clinical trials is a critical process. Along with resource hiring, it also requires materials for different activities. Some of these materials can be investigational products. But, a vast number of products could be non-investigational products necessary for the conduct of clinical trials. It becomes critical to plan for procurement or import of [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":4093,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"cybocfi_hide_featured_image":"","footnotes":""},"categories":[566,4],"tags":[267,425,149,330,148,134],"class_list":["post-4089","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-development","category-regulatory","tag-clinical-trial","tag-import","tag-japan","tag-mhlw","tag-pmda","tag-regulatory"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Import of Clinical Trial Ancillary Into Japan | Credevo Articles<\/title>\n<meta name=\"description\" content=\"For clinical trials, It becomes important to plan for procurement or import of clinical trial ancillary supply products well in advance\" 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