Exclusion of Regional Regulatory Authorities as HSA Reference Agencies and Impacts on Acceleration of Drug Access

10 Mr Kenneth Tiong Boon Kiat asked 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.

Mr Ong Ye Kung: The Health Sciences Authority (HSA) currently recognises six reference agencies – the 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.

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 days turnaround time for therapeutic product registration, which is fast by international standards.

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.