{"id":6104,"date":"2025-07-30T16:35:38","date_gmt":"2025-07-30T07:35:38","guid":{"rendered":"https:\/\/clinchoice.co.jp\/en\/?p=6104"},"modified":"2025-07-30T16:36:36","modified_gmt":"2025-07-30T07:36:36","slug":"vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025","status":"publish","type":"post","link":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/","title":{"rendered":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion &#8211; August 2025"},"content":{"rendered":"\n<p>Welcome to our August 2025 Vietnam Health Regulatory Update. This month, we spotlight three key regulatory developments that are shaping the pharmaceutical landscape in Vietnam. These changes may offer both compliance challenges and strategic opportunities for Japanese pharmaceutical companies.<\/p>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong><strong>1. New Circular 30\/2025: Drug Quality Standards and Recall Procedures<\/strong><\/strong><\/summary>\n<p>Effective July 1, 2025, Circular No.\u202f30\/2025\/TT-BYT replaces Circular\u202f11\/2018, bringing comprehensive updates to drug quality assurance and recall protocols.<\/p>\n\n\n\n<p><strong><strong>Key updates include:<\/strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Recognition of Japanese Pharmacopoeia (JP):<\/strong> Companies may now use JP alongside other international pharmacopoeias (USP, EP, BP), providing enhanced flexibility in dossier preparation and product testing.<\/li>\n\n\n\n<li><strong>Electronic recall notification system:<\/strong> Mandatory reporting of substandard products through a centralized platform, with clearer timelines and responsibilities.\u3002<\/li>\n\n\n\n<li><strong>Simplified processes for non-critical recalls<\/strong>, reducing disruption and improving risk-based management.<\/li>\n<\/ul>\n\n\n\n<p><strong>Official Source (Vietnamese): <\/strong><a href=\"https:\/\/chinhphu.vn\/?pageid=27160&amp;docid=214353&amp;classid=1&amp;orggroupid=4\"><strong>Government Portal \u2013 Circular 30\/2025\/TT-BYT on Drug Quality and Recall<\/strong><\/a><\/p>\n<\/details>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>2. Decree 163\/2025 &amp; Circular 31\/2025: E-Commerce and Controlled Substances<\/strong><\/summary>\n<p>These new provisions mark a significant shift in pharmaceutical distribution and compliance:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Legalization of pharmaceutical e-commerce:<\/strong> Online platforms can now sell drugs legally if they publicly display valid business licenses and pharmacy professional certifications.<\/li>\n\n\n\n<li><strong>Simplified destruction of controlled substances:<\/strong> Narcotics and psychotropics can now be destroyed with a 7-day advance notice, removing the need for prior MOH approval and easing operational burdens.<\/li>\n<\/ul>\n\n\n\n<p>This opens up new commercial channels while requiring strict documentation transparency.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Official Source (Vietnamese):<\/strong> <a href=\"https:\/\/chinhphu.vn\/?pageid=27160&amp;docid=214322&amp;classid=1#:~:text=Ngh%E1%BB%8B%20%C4%91%E1%BB%8Bnh%20s%E1%BB%91%20163%2F2025%2FN%C4%90-CP%20c%E1%BB%A7a%20Ch%C3%ADnh%20ph%E1%BB%A7%3A%20Quy,ban%20h%C3%A0nh%2029-06-2025%20Ng%C3%A0y%20c%C3%B3%20hi%E1%BB%87u%20l%E1%BB%B1c%2001-07-2025\"><strong>Government Portal \u2013 Decree 163\/2025\/ND-CP on Pharmaceutical E-commerce and Controlled Substance Disposal<\/strong><\/a><\/li>\n\n\n\n<li><strong>Official Source (Vietnamese): <\/strong><a href=\"https:\/\/chinhphu.vn\/?pageid=27160&amp;docid=214393\"><strong>Government Portal \u2013 Circular 31\/2025\/TT-BYT Detailed Guidelines on Implementation of the Law on Pharmacy and Decree 163\/2025\/ND-CP<\/strong><\/a><\/li>\n<\/ul>\n<\/details>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>3. <strong>Amended Law on Pharmacy (Law 44\/2024): Investment Incentives and Streamlined Registration<\/strong><\/strong><\/summary>\n<p>The amended Pharmacy Law introduces major reforms aimed at attracting investment and accelerating drug market access:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pharma R&amp;D and manufacturing designated as \u201cpriority sectors,\u201d<\/strong> enabling access to tax incentives and land-use privileges for qualifying projects (\u2265 VND 3,000 billion \/ ~JPY 15 billion).<\/li>\n\n\n\n<li><strong>Shortened registration timelines:<\/strong> Supplementation is now limited to two rounds, with a third only in exceptional cases.<\/li>\n\n\n\n<li><strong>Simplified renewal applications<\/strong> if product quality has remained stable over the license term.<\/li>\n<\/ul>\n\n\n\n<p>These changes aim to improve regulatory predictability for foreign manufacturers.<\/p>\n\n\n\n<p><em>Official Source (Vietnamese): <\/em><a href=\"https:\/\/vanban.chinhphu.vn\/?pageid=27160&amp;docid=212466&amp;classid=1&amp;typegroupid=3\"><strong>Government Portal \u2013 Law 44\/2024\/QH15 Amending the Law on Pharmacy<\/strong><\/a><\/p>\n<\/details>\n\n\n\n<p><\/p>\n\n\n\n<p>We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you require further details or assistance in navigating these changes, please do not hesitate to contact us.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Welcome to our August 2025 Vietnam Health Regulatory Update. This month, we spotlight three key regulatory developments that are shaping the pharmaceutical landscape in Vietnam. These changes may offer both compliance challenges and strategic opportunities for Japanese pharmaceutical companies. We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"vkexunit_cta_each_option":"","footnotes":""},"categories":[43],"tags":[],"class_list":["post-6104","post","type-post","status-publish","format-standard","hentry","category-regulatory-watch"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice<\/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:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice\" \/>\n<meta property=\"og:description\" content=\"Welcome to our August 2025 Vietnam Health Regulatory Update. This month, we spotlight three key regulatory developments that are shaping the pharmaceutical landscape in Vietnam. These changes may offer both compliance challenges and strategic opportunities for Japanese pharmaceutical companies. We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"ClinChoice\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-30T07:35:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-30T07:36:36+00:00\" \/>\n<meta name=\"author\" content=\"fmdkljp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"fmdkljp\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\"},\"author\":{\"name\":\"fmdkljp\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/7c0805159552b176bae1cbe4c35462bf\"},\"headline\":\"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion &#8211; August 2025\",\"datePublished\":\"2025-07-30T07:35:38+00:00\",\"dateModified\":\"2025-07-30T07:36:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\"},\"wordCount\":392,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#organization\"},\"articleSection\":[\"Regulatory Watch\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\",\"url\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\",\"name\":\"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice\",\"isPartOf\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#website\"},\"datePublished\":\"2025-07-30T07:35:38+00:00\",\"dateModified\":\"2025-07-30T07:36:36+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/clinchoice.co.jp\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion &#8211; August 2025\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#website\",\"url\":\"https:\/\/clinchoice.co.jp\/en\/\",\"name\":\"ClinChoice\",\"description\":\"The Standard of Excellence\",\"publisher\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/clinchoice.co.jp\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#organization\",\"name\":\"ClinChoice\",\"url\":\"https:\/\/clinchoice.co.jp\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#\/schema\/logo\/image\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"ClinChoice\"},\"image\":{\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/7c0805159552b176bae1cbe4c35462bf\",\"name\":\"fmdkljp\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/5cf8efce9e28da465cee96880d8e6dc5855c7a1da77f530ae839922d2c978441?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/5cf8efce9e28da465cee96880d8e6dc5855c7a1da77f530ae839922d2c978441?s=96&d=mm&r=g\",\"caption\":\"fmdkljp\"},\"url\":\"https:\/\/clinchoice.co.jp\/en\/author\/fmdkljp\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/","og_locale":"en_US","og_type":"article","og_title":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice","og_description":"Welcome to our August 2025 Vietnam Health Regulatory Update. This month, we spotlight three key regulatory developments that are shaping the pharmaceutical landscape in Vietnam. These changes may offer both compliance challenges and strategic opportunities for Japanese pharmaceutical companies. We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you [&hellip;]","og_url":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/","og_site_name":"ClinChoice","article_published_time":"2025-07-30T07:35:38+00:00","article_modified_time":"2025-07-30T07:36:36+00:00","author":"fmdkljp","twitter_card":"summary_large_image","twitter_misc":{"Written by":"fmdkljp","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#article","isPartOf":{"@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/"},"author":{"name":"fmdkljp","@id":"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/7c0805159552b176bae1cbe4c35462bf"},"headline":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion &#8211; August 2025","datePublished":"2025-07-30T07:35:38+00:00","dateModified":"2025-07-30T07:36:36+00:00","mainEntityOfPage":{"@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/"},"wordCount":392,"commentCount":0,"publisher":{"@id":"https:\/\/clinchoice.co.jp\/en\/#organization"},"articleSection":["Regulatory Watch"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/","url":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/","name":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion - August 2025 - ClinChoice","isPartOf":{"@id":"https:\/\/clinchoice.co.jp\/en\/#website"},"datePublished":"2025-07-30T07:35:38+00:00","dateModified":"2025-07-30T07:36:36+00:00","breadcrumb":{"@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/clinchoice.co.jp\/en\/vietnam-regulatory-watch-drug-regulatory-reforms-and-e-commerce-expansion-august-2025\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/clinchoice.co.jp\/en\/"},{"@type":"ListItem","position":2,"name":"Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion &#8211; August 2025"}]},{"@type":"WebSite","@id":"https:\/\/clinchoice.co.jp\/en\/#website","url":"https:\/\/clinchoice.co.jp\/en\/","name":"ClinChoice","description":"The Standard of Excellence","publisher":{"@id":"https:\/\/clinchoice.co.jp\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/clinchoice.co.jp\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/clinchoice.co.jp\/en\/#organization","name":"ClinChoice","url":"https:\/\/clinchoice.co.jp\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clinchoice.co.jp\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"ClinChoice"},"image":{"@id":"https:\/\/clinchoice.co.jp\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/7c0805159552b176bae1cbe4c35462bf","name":"fmdkljp","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clinchoice.co.jp\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/5cf8efce9e28da465cee96880d8e6dc5855c7a1da77f530ae839922d2c978441?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/5cf8efce9e28da465cee96880d8e6dc5855c7a1da77f530ae839922d2c978441?s=96&d=mm&r=g","caption":"fmdkljp"},"url":"https:\/\/clinchoice.co.jp\/en\/author\/fmdkljp\/"}]}},"_links":{"self":[{"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/posts\/6104","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/comments?post=6104"}],"version-history":[{"count":1,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/posts\/6104\/revisions"}],"predecessor-version":[{"id":6105,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/posts\/6104\/revisions\/6105"}],"wp:attachment":[{"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/media?parent=6104"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/categories?post=6104"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clinchoice.co.jp\/en\/wp-json\/wp\/v2\/tags?post=6104"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}