{"id":41314,"date":"2026-06-04T08:36:10","date_gmt":"2026-06-04T08:36:10","guid":{"rendered":"https:\/\/www.europesays.com\/korea\/41314\/"},"modified":"2026-06-04T08:36:10","modified_gmt":"2026-06-04T08:36:10","slug":"south-korea-to-cut-new-drug-approval-reviews-to-240-days","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/korea\/41314\/","title":{"rendered":"South Korea to cut new drug approval reviews to 240 days"},"content":{"rendered":"<p>\t\t\t\t\t\tSouth Korea to cut new drug approval reviews to 240 days<\/p>\n<p class=\"float-left\">June 4, 2026 | Thursday | News<\/p>\n<p>\t\t\t\t\t\t\tApproval and review innovation grants Korean citizens the fastest access to medical treatments in the world<\/p>\n<p>\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.europesays.com\/korea\/wp-content\/uploads\/2026\/06\/11-27739.jpg\" class=\"img-fluid w-100 pl-5 pr-5\" alt=\"image credit- shutterstock\"\/><\/p>\n<p class=\"mt-3 text-center\">image credit- shutterstock<\/p>\n<p style=\"text-align: justify;\">The Ministry of Food and Drug Safety (MFDS) in South Korea\u00a0has established the &#8220;Medical Product Approval and Review Innovation Plan&#8221; to expand medical treatment opportunities for citizens through the expedited approval and review of new drugs, biosimilars, and innovative medical devices, and will implement it immediately.\u00a0<\/p>\n<p style=\"text-align: justify;\">This innovation plan aims to expand patient treatment opportunities and support K-Bio&#8217;s global leap by rapidly launching safe treatments within a target timeframe of 240 days.<\/p>\n<p style=\"text-align: justify;\">Efforts will be made to shorten the approval period by shifting to a simultaneous and parallel review system through the hiring of 195 new approval and review personnel, and by conducting face-to-face meetings prior to filing application as well as deficiency resolution meetings during the review stage.<\/p>\n<p style=\"text-align: justify;\">Previously, inquiries regarding upcoming new drug applications were addressed through one-time consultations, but no official written documentation was provided afterward.<\/p>\n<p style=\"text-align: justify;\">To offer more substantial practical assistance to companies preparing approval and review dossiers, the MFDS will utilise its expanded personnel to strengthen communication by conducting two or more official &#8220;Pre-NDA Meetings.&#8221;<\/p>\n<p style=\"text-align: justify;\">Previously, due to a shortage of review personnel, a limited number of experts had to review massive amounts of data sequentially, resulting in extended review timelines. <\/p>\n<p style=\"text-align: justify;\">Moving forward, the MFDS will deploy a larger pool of reviewers to form dedicated teams for each review category, executing a fast-paced &#8220;Simultaneous and Parallel Review.&#8221;<\/p>\n<p style=\"text-align: justify;\">Applications for &#8220;Pre-NDA Meetings&#8221; for new drugs, biosimilars and innovative medical devices has opened on June 1.<\/p>\n","protected":false},"excerpt":{"rendered":"South Korea to cut new drug approval reviews to 240 days June 4, 2026 | Thursday | News&hellip;\n","protected":false},"author":2,"featured_media":41315,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[18314,6918,31,430,24871,33],"class_list":["post-41314","post","type-post","status-publish","format-standard","has-post-thumbnail","category-south-korea","tag-approval","tag-drug","tag-korea","tag-mfds","tag-shorten-timeline","tag-south-korea"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/41314","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/comments?post=41314"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/41314\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media\/41315"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media?parent=41314"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/categories?post=41314"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/tags?post=41314"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}