{"id":5213,"date":"2024-06-19T12:13:50","date_gmt":"2024-06-19T12:13:50","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=5213"},"modified":"2025-11-26T11:44:30","modified_gmt":"2025-11-26T11:44:30","slug":"pharma-biotech-usa-europe-asia-and-row-regulatory-news-may-2024","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-asia-and-row-regulatory-news-may-2024\/","title":{"rendered":"Pharma\/Biotech \u2013 USA, Europe, Asia and ROW Regulatory News \u2013 May 2024"},"content":{"rendered":"\n<span  id=\"usa\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">USA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EPA, FDA, and USDA Release Joint Biotechnology Regulatory Plan<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In alignment with President Biden\u2019s Executive Order 14081, the EPA, FDA, and USDA have issued a coordinated plan to modernize and clarify regulatory oversight for biotechnology products. The initiative aims to streamline processes and support innovation while ensuring safety within the U.S. bioeconomy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Approves First Interchangeable Biosimilar for Two Rare Diseases<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab). It is approved for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Reducing hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH).\u00a0<\/li>\n\n\n\n<li>Inhibiting complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome (aHUS).\u00a0<\/li>\n<\/ul>\n\n\n\n<span  id=\"europe\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">EUROPE<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Conditional Approval Recommended for New Haemophilia B Gene Therapy<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EMA has recommended conditional marketing authorization for Durveqtix (fidanacogene elaparvovec) to treat adults with severe or moderately severe haemophilia B who lack factor IX inhibitors and have no detectable antibodies to AAVRh74var.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>First EU Vaccine Against Chikungunya Receives Positive Recommendation<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EMA has recommended approval of Ixchiq, the first EU vaccine for adults aged 18 and older to protect against Chikungunya, a mosquito-borne viral illness. It is administered as a single dose.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA Recommends Suspension of 17-OHPC Medicines<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EMA\u2019s PRAC committee has recommended suspending the authorization of medicines containing 17-hydroxyprogesterone caproate (17-OHPC). Concerns include a potential\u2014but unconfirmed\u2014risk of cancer associated with in\u2011utero exposure, and new evidence suggesting the product does not prevent premature birth.<\/p>\n\n\n\n<span  id=\"australia\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">AUSTRALIA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>GMP Forum 2024 Scheduled for November<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The TGA will host its annual two-day GMP Forum in November. The event will provide regulatory insights, interactive sessions, and expanded networking opportunities for industry stakeholders.<\/p>\n\n\n\n<span  id=\"canada\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">CANADA<\/h3>.\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Upcoming Announcement on Seniors\u2019 Health Care<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Federal and provincial ministers will make a joint announcement addressing new initiatives related to seniors\u2019 healthcare in Canada.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Statement on Canada\u2019s Overdose Crisis<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Minister of Mental Health and Addictions emphasized the severity of the ongoing overdose crisis. Driven by an increasingly toxic illegal drug supply, the crisis demands a comprehensive response spanning prevention, harm reduction, treatment, and enforcement.<\/p>\n\n\n\n<span  id=\"india\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">INDIA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Withdrawal of an Indication for Olaparib Tablets<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulators have withdrawn the indication for Olaparib 100 mg\/150 mg tablets used to treat gBRCA\u2011mutated advanced ovarian cancer in patients previously treated with three or more lines of chemotherapy. Other approved indications for ovarian and breast cancer remain unchanged.<\/p>\n\n\n\n<span  id=\"malaysia\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">MALAYSIA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Updated Application Forms for Biologics<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NPRA has released updated application forms for biologics to support regulatory submissions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Revised Timelines for Variation Applications<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NPRA plans revisions to timelines for variations to registered products across pharmaceuticals, biologics, and natural\/health supplement categories to enhance clarity and efficiency.<\/p>\n\n\n\n<span  id=\"singapore\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;font-weight:bold;\">SINGAPORE<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Update on Reclassified Medicines<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Singapore uses three access levels for therapeutic products:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Prescription Only Medicines (POM) \u2013 require diagnosis and supervision by a doctor.<\/li>\n\n\n\n<li>Pharmacy Only Medicines (P) \u2013 available from pharmacists for self-limiting conditions.<\/li>\n\n\n\n<li>General Sale List (GSL) \u2013 available for self-care without medical oversight.<\/li>\n<\/ul>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-1972be6905e9b3248c02713809b879c1 wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><strong><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\">Tags:<\/mark><\/strong>  <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/bio-pharma\/\" rel=\"tag\">Bio Pharma<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/bio-tech\/\" rel=\"tag\">Bio Tech<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/biotech-news\/\" rel=\"tag\">Biotech News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/biotechnology\/\" rel=\"tag\">Biotechnology<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/drug-approval\/\" rel=\"tag\">Drug Approval<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/ema\/\" rel=\"tag\">EMA<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/fda\/\" rel=\"tag\">FDA<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/global-health\/\" rel=\"tag\">Global Health<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/health-news\/\" rel=\"tag\">Health News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/healthcare\/\" rel=\"tag\">Healthcare<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/healthcare-innovation\/\" rel=\"tag\">Healthcare Innovation<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-updates\/\" rel=\"tag\">Medical Updates<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma-industry\/\" rel=\"tag\">Pharma Industry<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma-news\/\" rel=\"tag\">Pharma News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma-regulations\/\" rel=\"tag\">Pharma Regulations<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma-trends\/\" rel=\"tag\">Pharma Trends<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma2024\/\" rel=\"tag\">Pharma2024<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharmaceuticals\/\" rel=\"tag\">Pharmaceuticals<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/regulatory-updates\/\" rel=\"tag\">Regulatory Updates<\/a><\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>USA EPA, FDA, and USDA Release Joint Biotechnology Regulatory Plan In alignment with President Biden\u2019s Executive Order 14081, the EPA, FDA, and USDA have issued a coordinated plan to modernize and clarify regulatory oversight for biotechnology products. The initiative aims to streamline processes and support innovation while ensuring safety within the U.S. bioeconomy. FDA Approves [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1951,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[639],"tags":[689,690,577,680,183,221,144,565,691,164,413,692,207,694,579,693,682,197,102],"class_list":["post-5213","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-bio-pharma","tag-bio-tech","tag-biotech-news","tag-biotechnology","tag-drug-approval","tag-ema","tag-fda","tag-global-health","tag-health-news","tag-healthcare","tag-healthcare-innovation","tag-medical-updates","tag-pharma-industry","tag-pharma-news","tag-pharma-regulations","tag-pharma-trends","tag-pharma2024","tag-pharmaceuticals","tag-regulatory-updates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Global Pharma Health Products and Biotech 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