EXCLUSION OF REGIONAL REGULATORY AUTHORITIES AS HSA REFERENCE AGENCIES AND IMPACTS ON ACCELERATION OF DRUG ACCESS

NOTICE PAPER NO. 331

NOTICE OF QUESTION FOR WRITTEN ANSWER

FOR THE SITTING OF PARLIAMENT ON 13 JANUARY 2026

Name and Constituency of Member of Parliament

Mr Kenneth Tiong Boon Kiat

MP for Aljunied GRC

Question No. 678

To ask the Coordinating Minister for Social Policies and Minister for Health (a) what specific technical or regulatory barriers prevent the inclusion of Japan’s Pharmaceuticals and Medical Devices Agency and South Korea’s Ministry of Food and Drug Safety as reference agencies for therapeutic product registration; (b) to what extent does such exclusion delay the registration of medicines optimised for regional populations; and (c) whether the Ministry will conduct a feasibility study on recognising such World Health Organisation Listed Authorities as HSA's reference agencies, to accelerate drug access.

Answer

1          The Health Sciences Authority (HSA) currently recognises six reference agencies - US Food and Drug Administration (US FDA), European Medicines Agency (EMA), Health Canada, Therapeutic Goods Administration (TGA) of Australia, Swissmedic, and Medicines and Health Products Regulatory Agency (MHRA) of the United Kingdom.

2          This current six reference jurisdictions comprise major markets which typically receive first-wave filings from pharmaceutical companies, of which HSA has established collaborative evaluation process and joint review with.  This includes aligned scientific standards for quality, safety and efficacy, as well as access to comprehensive scientific assessment and evaluation reports in English that HSA can rely upon for its verification process. Through these arrangements, we could offer an expedited 60 working day turning around time for therapeutic product registration, which is fast by international standards.

3          HSA continuously reviews its regulatory framework to ensure patients in Singapore have optimal access to safe and effective therapeutic products.  Hence, HSA is in talks with other WHO-Listed Authorities, including Japan and South Korea, to explore closer regulatory cooperation initiatives.