Chasing Everything New

​

There have been notable developments in AI governance for drug discovery and clinical trials across Asia Pacific, especially within leading ASEAN and RCEP economies. The region is advancing policy frameworks, regulatory sandboxes, ethical guidelines, and practical adoption of AI-based technologies in pharmaceutical R&D and clinical research.bain+3

• ASEAN AI Governance Roadmap and Guide:
  ASEAN has introduced a Responsible AI Roadmap (2025–2030) and endorsed an AI Governance and Ethics Guide, giving actionable steps for ethical and responsible AI deployment in healthcare and pharma. The focus is on establishing harmonized, interoperable regulations and ethical standards, with specific guidance for drug discovery and clinical trials.linkedin+1​
• National Regulatory Sandboxes and Pilots:
  Malaysia launched the first regulatory sandbox for AI-driven medical devices in partnership with its Medical Device Authority (MDA), providing a controlled environment for validation, assessment, and safe adoption of AI in healthcare products, including clinical trials. These sandboxes allow real-world trials of AI innovations under regulatory oversight, accelerating responsible adaptation.andamanmed​
• Practical Integration and Regulatory Reliance:
  China, South Korea, Japan, and Singapore are streamlining approval processes to compete as regional R&D hubs by accepting global trial data and leveraging AI for review and application analysis. Thailand’s FDA uses AI-powered tools to analyze medical device applications, improving consistency and reducing review times.globalforum.diaglobal+1​
• Ethical Principles and Human Oversight:
  Responsible AI governance in clinical trials includes requirements for transparency, explainability, and oversight in decision-making and data analysis. Compliance audits, ethical reviews, and safeguards are becoming standard practice, especially where AI supports regulatory or clinical trial processes.openreview+1​
• Investment and Infrastructure Upgrades:
  Governments such as Singapore have committed substantial funding for biotech and AI research, with plans like RIE2025 prioritizing the development of dual-skilled talent (scientific and AI expertise) and advanced research platforms to accelerate AI adoption in drug discovery and clinical development.bain​

These initiatives mark a strategic shift, positioning Asia Pacific as a leader in responsible, innovative, and competitive use of AI in drug development and clinical trials, supported by harmonized governance and adaptive regulatory models.asean-bac+5​

1. https://www.bain.com/insights/empowering-biotech-innovation-in-asia-pacific/
2. https://globalforum.diaglobal.org/issue/september-2025/regulatory-excellence-and-reliance-technology-transformation-and-clinical-trial-innovation-in-asia/
3. https://www.linkedin.com/posts/the-asean-secretariat_the-asean-responsible-ai-roadmap-2025-2030-activity-7302965604271964161-AqQB
4. https://asean-bac.org/news-and-press-releases/artificial-intelligence-(ai)-and-digital-transformation-in-the-asean-region
5. https://andamanmed.com/malaysia-futurise-lead-regtalk-2025-ai-medical-devices-in-malaysia-balancing-innovation-and-safety/
6. https://openreview.net/pdf?id=HOteLn0CIn
7. https://www.towardshealthcare.com/insights/ai-and-ml-in-drug-development-market-sizing
8. https://www.edb.gov.sg/en/business-insights/market-and-industry-reports/empowering-biotech-innovation-in-asia-pacific.html
9. https://blogs.idc.com/2025/07/11/ai-powered-healthcare-in-asia-pacific-whats-next-for-2025-and-beyond/
10. https://msfaccess.org/sites/default/files/ACCESS_Brief_RCEPTradingAwayHealth_ENG_2016_0.pdf
11. https://blogs.adb.org/blog/generative-ai-can-revitalize-asia-and-pacific-s-analog-health-care
12. https://www.freyrsolutions.com/blog/5-key-updates-you-need-to-know-about-chinas-2025-trade-agreements-for-the-pharmaceutical-sector
13. https://www.iqvia.com.kh/locations/asia-pacific/library/white-papers/from-hype-to-impact-unlocking-ai-full-potential-in-asia-pacific-pharma
14. https://www.sciencedirect.com/science/article/pii/S1326020023012347
15. https://avpn.asia/wp-content/uploads/2025/04/AI-for-All-Building-an-AI-Ready-Workforce-in-Asia-Pacific.pdf
16. https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1650225/full
17. https://assets.kpmg.com/content/dam/kpmg/cn/pdf/en/2025/03/realizing-the-value-of-ai-in-medtech-within-asia-pacific.pdf
18. https://www.nbr.org/publication/charting-aseans-path-to-ai-governance-uneven-yet-gaining-ground/
19. https://www.tandfonline.com/doi/full/10.1080/10192557.2024.2349387
20. https://practiceguides.chambers.com/practice-guides/artificial-intelligence-2025/singapore/trends-and-developments