{"id":11083,"date":"2026-09-01T19:34:41","date_gmt":"2026-09-01T11:34:41","guid":{"rendered":"https:\/\/regask.com\/?p=11083"},"modified":"2026-09-01T19:34:41","modified_gmt":"2026-09-01T11:34:41","slug":"%e3%83%a9%e3%82%a4%e3%83%95%e3%82%b5%e3%82%a4%e3%82%a8%e3%83%b3%e3%82%b9%e8%a6%8f%e5%88%b6%e3%82%92%e5%bd%a2%e6%88%90%e3%81%99%e3%82%8b5%e3%81%a4%e3%81%ae%e3%83%88%e3%83%ac%e3%83%b3%e3%83%89","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/5-trends-shaping-life-sciences-regulation\/","title":{"rendered":"\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u898f\u5236\u3092\u5f62\u6210\u3059\u308b5\u3064\u306e\u30c8\u30ec\u30f3\u30c9"},"content":{"rendered":"<p><b><span data-contrast=\"auto\">RegASK regulatory intelligence experts highlight five regulatory trends that stood out across life sciences between 25 July and 25 August 2026.<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Between <\/span><b><span data-contrast=\"auto\">25 July and 25 August 2026<\/span><\/b><span data-contrast=\"auto\">, RegASK\u2019s regulatory intelligence experts tracked developments affecting medicines, medical devices, clinical trials and digital health across multiple regions.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Five themes stood out for their regulatory momentum and potential impact on life sciences teams: modernization of post-market safety systems, wider use of regulatory reliance, coordinated attention on GLP-1 receptor agonists, evolving clinical-trial standards, and the growing role of AI and digital tools in regulation.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Here are the five trends to watch.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-1474735284\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1474735284 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW60914198 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW60914198 BCX0\" data-ccp-parastyle=\"heading 2\">Post-market safety systems are modernizing worldwide<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-157517668\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-157517668 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-2072376643\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2072376643 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><b><span data-contrast=\"auto\">Trend strength: High<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Post-market safety and pharmacovigilance was the broadest life sciences theme during the reporting period, with around 30 developments spanning eight regions and 18 jurisdictions.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Regulators are updating the infrastructure used to identify, report and act on safety signals.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Brazil\u2019s ANVISA opened consultations covering a National Pharmacovigilance System and technovigilance reform <\/span><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-fara-consulta-publica-para-criacao-do-sistema-nacional-de-farmacovigilancia\"><span data-contrast=\"none\">ANVISA.<\/span><\/a><span data-contrast=\"auto\"> South Africa\u2019s SAHPRA launched VigiFlow e-reporting <\/span><a href=\"https:\/\/www.sahpra.org.za\/sahpra-trains-mpumalanga-healthcare-workers-to-improve-medicine-and-vaccine-safety-reporting-through-electronic-reporting-tools\/\"><span data-contrast=\"none\">SAHPRA<\/span><\/a>,<span data-contrast=\"auto\"> while Argentina\u2019s ANMAT introduced a new adverse-event reporting form.<\/span><a href=\"https:\/\/www.argentina.gob.ar\/noticias\/nuevo-formulario-para-notificar-eventos-adversos-y-desvios-de-calidad-de-productos-medicos\"><span data-contrast=\"none\"> ANMAT<\/span><\/a><span data-contrast=\"auto\"> Mexico\u2019s COFEPRIS also published a national safety <\/span><a href=\"https:\/\/www.gob.mx\/cofepris\/articulos\/cofepris-robustece-la-farmacovigilancia-y-la-tecnovigilancia-con-la-publicacion-del-boletin-nacional-2026-i\"><span data-contrast=\"none\">COFEPRIS<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">At the same time, regulators continued responding to active safety signals. In Europe, PRAC activity led to new safety communications, including a <a href=\"https:\/\/www.bfarm.de\/SharedDocs\/Risikoinformationen\/Pharmakovigilanz\/DE\/RHB\/2026\/rhb-desogestrel-etonogestrel.html\">BfArM<\/a> direct healthcare professional communication on meningioma risk associated with desogestrel and etonogestrel.<\/span><\/p>\n<p><span data-contrast=\"auto\">Australia\u2019s <a href=\"https:\/\/www.tga.gov.au\/safety\/safety-monitoring-and-information\/medical-device-post-market-monitoring-and-safety-updates\/post-market-review-plastic-syringes\">TGA<\/a> also opened a post-market review of syringes and consulted on greater transparency around medical-device safety.<\/span><\/p>\n<p><span data-contrast=\"auto\">Taken together, these developments point toward <\/span><b><span data-contrast=\"auto\">more structured, digital and continuous approaches to post-market surveillance<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p aria-level=\"3\"><b><span data-contrast=\"none\">What this means for regulatory teams<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Pharmacovigilance and post-market monitoring are becoming increasingly embedded in regulatory infrastructure.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Teams need to track both individual safety signals and changes to the systems through which adverse events, device incidents and emerging risks are reported and managed.<\/span><strong>\u00a0<\/strong><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW181453751 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW181453751 BCX0\" data-ccp-parastyle=\"heading 2\">Regulatory reliance and accelerated-access pathways are expanding<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1393335912\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1393335912 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><b><span data-contrast=\"auto\">Trend strength: High<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Regulatory reliance was another major theme during the reporting period, with around 31 developments across North America, the Middle East, the EAEU, Europe, the UK and international regulatory bodies.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The direction is increasingly clear: regulators are creating pathways that allow them to make greater use of assessments or decisions from trusted authorities.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"https:\/\/www.who.int\/news\/item\/01-12-2025-who-issues-global-guideline-on-the-use-of-glp-1-medicines-in-treating-obesity\">Health Canada<\/a>\u2019s Ministerial Reliance Order came into force on 15 July, alongside consultation on a foreign-reliance pathway.<\/span><\/p>\n<p><span data-contrast=\"auto\">Saudi Arabia\u2019s SFDA introduced its Rapid Access to Innovative Drugs designation and became the first regulator to register iberdomide <\/span><a href=\"https:\/\/sfda.gov.sa\/en\/news\/19261\"><span data-contrast=\"none\">SFDA<\/span><\/a><span data-contrast=\"auto\"> The UAE also authorized novel medicines shortly afterward.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">At the international level, <a href=\"https:\/\/www.who.int\/news\/item\/23-07-2026-who-advances-global-regulatory-cooperation-with-first-interim-list-of-regulatory-authorities-for-medical-devices\">WHO<\/a> published its first interim list of Transitional WHO-Listed Authorities for medical devices.<\/span><\/p>\n<p><span data-contrast=\"auto\">In the UK, MHRA activity through the Innovative Licensing and Access Pathway also supported accelerated authorization, including the European authorization of oral orforglipron.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The broader trend is a shift toward <\/span><b><span data-contrast=\"auto\">reliance pathways that are increasingly operational rather than simply under discussion<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p aria-level=\"3\"><b><span data-contrast=\"none\">What this means for regulatory teams<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Global submission strategies may need to account for a growing number of reliance and accelerated-access pathways.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Understanding which regulators recognize external assessments, what evidence is required and when a product may qualify could influence filing sequences and market-access planning.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW9022868 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW9022868 BCX0\" data-ccp-parastyle=\"heading 2\">GLP-1 receptor agonists are becoming a coordinated global regulatory story<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-476848327\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-476848327 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><b><span data-contrast=\"auto\">Trend strength: Medium<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Supplements and functional products are also moving toward more structured oversight.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Trend strength: High<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">GLP-1 receptor agonists stood out as a distinct regulatory theme during the reporting period, with market expansion and safety oversight developing in parallel.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"https:\/\/www.who.int\/news\/item\/01-12-2025-who-issues-global-guideline-on-the-use-of-glp-1-medicines-in-treating-obesity\">WHO<\/a> advisory committees issued a joint statement on the safe and appropriate use of GLP-1 receptor agonists, bringing coordinated international attention to the class. <\/span><\/p>\n<p><span data-contrast=\"auto\">At the same time, oral orforglipron received regulatory approvals across several markets within a short period, including the UK <\/span><a href=\"https:\/\/www.gov.uk\/government\/news\/uk-first-in-europe-to-authorise-orforglipron-for-weight-management-and-type-2-diabetes\"><span data-contrast=\"none\">MHRA<\/span><\/a><span data-contrast=\"auto\"> Saudi Arabia under the name Foundayo, <\/span><a href=\"https:\/\/www.sfda.gov.sa\/en\/news\/19225\"><span data-contrast=\"none\">SFDA<\/span><\/a><span data-contrast=\"auto\"> and the UAE <\/span><a href=\"https:\/\/www.ede.gov.ae\/en\/w\/emirates-drug-establishment-approves-oral-obesity-treatment-marking-shift-away-from-injections\"><span data-contrast=\"none\">EDE.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The combination is significant.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">As the class expands into more markets, regulators are also establishing a broader framework for monitoring appropriate use and safety.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p aria-level=\"3\"><b><span data-contrast=\"none\">What this means for regulatory teams<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">GLP-1 receptor agonists now warrant dedicated regulatory monitoring across approvals, safety communications and post-market requirements.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For companies operating in or around the category, a class-level view may be more useful than monitoring individual products or markets separately.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW211947147 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW211947147 BCX0\" data-ccp-parastyle=\"heading 2\">Clinical-trial standards are converging while eligibility broadens<\/span><\/span><\/strong><\/h3>\n<p><b><span data-contrast=\"auto\">Trend strength: Medium-high<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Clinical-trial regulation is moving toward greater international alignment alongside efforts to broaden participation.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf\">ICH<\/a> E6(R3) Good Clinical Practice became the operative reference standard from 15 July, providing an updated framework for the conduct of clinical trials.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In the US, FDA finalized three guidances addressing eligibility criteria in cancer clinical trials, covering performance status, laboratory values, and washout periods and concomitant medications.<\/span> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cancer-clinical-trial-eligibility-criteria-washout-periods-and-concomitant-medications\"><span data-contrast=\"none\">FDA<\/span><\/a><span data-contrast=\"auto\"> also ran its Expedited IND pilot.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Elsewhere, India\u2019s CDSCO <\/span><a href=\"https:\/\/www.icmr.gov.in\/post\/public-consultation-icmr-operational-guidelines-for-single-ethics-review-of-multicentre-research-in-india-last-date-march-6-2026\"><span data-contrast=\"none\">ICMR<\/span><\/a><span data-contrast=\"auto\"> on the use of a single ethics-committee review for multicenter trials, while <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/clinical-trials\/search-portal\/notice.html\">Health Canada<\/a> launched a public clinical-trials search portal.<\/span><\/p>\n<p><span data-contrast=\"auto\">Together, these developments point toward <\/span><b><span data-contrast=\"auto\">more modernized trial standards, streamlined oversight and deliberate efforts to broaden participation<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p aria-level=\"3\"><b><span data-contrast=\"none\">What this means for regulatory teams<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Clinical teams need to account for both changes to GCP expectations and evolving national approaches to trial design and oversight.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Eligibility criteria, ethics review and transparency requirements can all affect protocol development, site planning and regulatory submissions.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW8514333 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW8514333 BCX0\" data-ccp-parastyle=\"heading 2\">AI and digital tools are moving deeper into medicines regulation<\/span><\/span><\/strong><\/h3>\n<p><b><span data-contrast=\"auto\">Trend strength: Medium<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Regulators are also building frameworks for AI-enabled products, digital tools and new forms of regulatory information.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The <a href=\"https:\/\/digital-strategy.ec.europa.eu\/en\/policies\/regulatory-framework-ai\">EU AI Act<\/a> became generally applicable on 2 August, creating a wider regulatory backdrop for organizations developing or deploying AI systems.<\/span><\/p>\n<p><span data-contrast=\"auto\">In the UK, the <a href=\"https:\/\/www.gov.uk\/government\/news\/pioneering-ai-health-innovations-regulatory-sandbox-launched\">MHRA<\/a> launched an AI health-innovation regulatory sandbox with NHS England.<\/span><\/p>\n<p><span data-contrast=\"auto\">At the international level, the <a href=\"https:\/\/www.imdrf.org\/sites\/default\/files\/2026-04\/IMDRF%20AIML%20WG%20N93%20DRAFT%202026%20-%20Technical%20Framework%20for%20Artificial%20Intelligence%20Life%20Cycle%20Management.pdf\">International Medical Device Regulators Forum<\/a> advanced its technical framework for AI lifecycle management in medical devices through N93.<\/span><\/p>\n<p><span data-contrast=\"auto\">Brazil also moved forward with digital medication package inserts.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">These developments are still at different stages of maturity, but together they show regulators working on <\/span><b><span data-contrast=\"auto\">AI governance and digital regulatory infrastructure at the same time<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p aria-level=\"3\"><b><span data-contrast=\"none\">What this means for regulatory teams<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">AI and digitalization are becoming relevant across more parts of the regulatory lifecycle.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Teams need to monitor requirements affecting AI-enabled products as well as changes to the regulatory processes, information formats and oversight mechanisms surrounding them.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW247487842 BCX0\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW247487842 BCX0\" data-ccp-parastyle=\"heading 2\">What connects these five trends?<\/span><\/span><span class=\"EOP Selected SCXW247487842 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n<p><span data-contrast=\"auto\">Across the 25 July to 25 August reporting period, life sciences regulators were focused on two priorities at once: <\/span><b><span data-contrast=\"auto\">speeding access to innovation while strengthening the systems that govern safety, evidence and oversight.<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">That balance appears across all five trends.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Reliance pathways are creating opportunities for faster approvals. Clinical-trial rules are being modernized. AI and digital tools are entering regulatory systems. At the same time, pharmacovigilance infrastructure is becoming more structured, and regulators are coordinating more closely around emerging safety issues.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For regulatory teams, understanding the individual development is only the beginning. They also need to know:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">which products, markets and submissions may be affected<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">whether new reliance or accelerated pathways are available<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">how clinical, safety or post-market requirements are changing<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">where new digital or AI requirements could create additional obligations<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">These five themes reflect the life sciences developments that stood out in RegASK\u2019s regulatory monitoring between <\/span><b><span data-contrast=\"auto\">25 July and 25 August 2026<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\">RegASK<\/a> monitors regulatory developments across <\/span><b><span data-contrast=\"auto\">160+ markets<\/span><\/b><span data-contrast=\"auto\">, supported by a global community of <\/span><b><span data-contrast=\"auto\">more than 1,800 regulatory experts<\/span><\/b><span data-contrast=\"auto\">, giving life sciences teams the intelligence they need to understand regulatory change, assess its impact and act across their workflows.<\/span><\/p>\n\n","protected":false},"excerpt":{"rendered":"<p>RegASK regulatory intelligence experts highlight five regulatory trends that stood out across life sciences between 25 July and 25 August 2026.\u00a0 Between 25 July and 25 August 2026, RegASK\u2019s regulatory intelligence experts tracked developments affecting medicines, medical devices, clinical trials and digital health across multiple regions.\u00a0 Five themes stood out for their regulatory momentum and potential impact on life sciences teams: modernization of post-market safety systems, wider use of regulatory reliance, coordinated attention on GLP-1 receptor agonists, evolving clinical-trial standards, and the growing role of AI and digital tools in regulation.\u00a0 Here are the five trends to watch.\u00a0 Post-market safety systems are modernizing worldwide Trend strength: High\u00a0 Post-market safety and&#8230;<\/p>","protected":false},"author":46,"featured_media":7918,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11083","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin 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