Written Answer · 2026-05-06 · Parliament 15
Regulatory Framework for AI-developed Drugs and Implications on Clinical Trials, and Adequacy of Data Protection Safeguards for National Patient Data
Mr Yip Hon Weng asked the Coordinating Minister for Social Policies and Minister for Health in writing whether the Ministry has studied if AI-developed drugs can shorten or bypass clinical trials; if so, how their regulatory approval would differ from conventional products; what regulations currently govern AI healthcare innovations; and whether existing personal data protection and cybersecurity safeguards can prevent data leakage when AI accesses national patient data for product conceptualisation. Health Minister Ong Ye Kung replied that both AI-developed and conventionally developed drugs must meet the same international standards of quality, safety and efficacy — no shortcuts. The Health Sciences Authority's regulatory approach is aligned with international agencies such as the US FDA and the European Medicines Agency, which have set out key principles on the responsible use of AI in drug development. Patient data is robustly protected, including under the Personal Data Protection Act, and the Government will continue to monitor developments and strengthen safeguards as needed. The reply affirmed a "same standards" principle: AI does not change the evidentiary bar for drug approval.
Key Points
- • Yip Hon Weng asked if AI-developed drugs can shorten or bypass clinical trials
- • Ong Ye Kung: AI and conventional drugs must meet the same international quality, safety and efficacy standards
- • HSA's regulatory approach is aligned with the US FDA and the European Medicines Agency
- • Patient data is robustly protected, including under the Personal Data Protection Act
AI-developed drugs get no regulatory shortcut — they must meet the same international quality, safety and efficacy standards as conventional drugs, and patient data is robustly protected with safeguards to be strengthened as needed.
Singapore is taking a "same standards" line on AI drug regulation, aligned with the FDA and EMA: AI may speed up drug development, but the safety evidence bar will not be lowered — a measured rather than aggressive approach to medical AI regulation.
"Both artificial intelligence- (AI-)developed and conventionally developed drugs must meet the same international standards of quality, safety and efficacy."
Participants (2)
Original Text (English)
SPRS Hansard · Fetched: 2026-06-09
16 Mr Yip Hon Weng asked the Coordinating Minister for Social Policies and Minister for Health (a) whether the Ministry has studied if AI-developed drugs can shorten or bypass clinical trials; (b) if so, how will the regulatory approval of AI-developed drugs differ from conventional products; (c) what regulations currently govern AI healthcare innovations; and (d) whether existing personal data protection and cybersecurity safeguards can prevent data leakage when AI accesses national patient data for product conceptualisation.
Mr Ong Ye Kung : Both artificial intelligence- (AI-)developed and conventionally developed drugs must meet the same international standards of quality, safety and efficacy. The Health Sciences Authority's regulatory approach is aligned with international agencies, such as the US Food and Drug Administration and the European Medicines Agency, that have outlined key principles on the responsible use of AI in drug development.
Patient data is robustly protected, including when used for AI development. Existing data protection and cybersecurity safeguards, including those under the Personal Data Protection Act, ensure that patient confidentiality is maintained and that the data is protected.
We will continue to monitor developments and strengthen our safeguards as needed.