{"schema_version":"1.0","type":"article","title":"Animal Studies Are Not Disappearing. Drug Development Rules Are Changing.","url":"https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift-en.html","markdown_url":"https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift-en.md","lang":"en","date":"2026-07-19","publish_at":"2026-07-19T08:36:00+08:00","updated_at":"2026-07-19","category":"商業分析系列","topic":"臨床與 CMC","tags":["NAMs","CDE","Regulatory Science","Organoids","Organ-on-a-Chip","AI Drug Discovery"],"summary":"China's CDE PIONEER program opens a regulatory pathway for new approach methodologies. The real test is whether human-relevant evidence becomes reproducible, validated and reusable.","key_points":[],"facts":[],"sections":["01 | CDE PIONEER has two doors and concrete use cases","02 | Regulators are moving, but they are not moving in the same way","03 | CDE's program is meaningful, but it is a starting point","04 | The value chain will be repriced around validated, reusable evidence","Conclusion | NAMs are about bringing drug development closer to people","References"],"references":[{"title":"CDE public consultation and PIONEER materials:","source":"","date":"","url":"https://www.cde.org.cn/"},{"title":"U.S. FDA, New Approach Methodologies:","source":"","date":"","url":"https://www.fda.gov/science-research/about-science-research-fda/new-approach-methodologies-nams"},{"title":"European Medicines Agency, regulatory science and qualification:","source":"","date":"","url":"https://www.ema.europa.eu/"},{"title":"UK Government, replacing animal testing roadmap:","source":"","date":"","url":"https://www.gov.uk/government/publications/replacing-animals-in-science-a-strategy-to-support-the-development-use-and-uptake-of-alternatives-to-animal-testing"},{"title":"This article is a synthesis of public regulatory and industry information. It does not constitute medical, investment, fundraising or stock advice. 本文不構成醫療、投資、募資或股票建議。*","source":"","date":"","url":""}],"images":[{"alt":"Three human-relevant evidence platforms: organoids, organ-on-a-chip technology and computational models","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift-en/figure-01.webp"},{"alt":"CDE PIONEER's two entry points for drug developers and method developers","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift-en/figure-02.webp"},{"alt":"FDA, EMA and MHRA illustrate different pathways toward regulatory acceptance of NAMs","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift-en/figure-03.webp"},{"alt":"Where NAMs can create value: organoids, CGT, AI validation and integrated CRO services","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift-en/figure-04.webp"}],"cover_image":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift-en/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-07-19）。Animal Studies Are Not Disappearing. Drug Development Rules Are Changing.。https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift-en.html","disclaimer":"This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.","translations":{"zh-Hant":"2026-07-19-nams-regulatory-shift.html"},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}