HSA'S REGULATORY PATHWAYS FOR NMPA-APPROVED MEDICINES

NOTICE PAPER NO. 954
NOTICE OF QUESTION FOR WRITTEN ANSWER
FOR THE SITTING OF PARLIAMENT ON 7 JULY 2026

Name and Constituency of Member of Parliament
Mr Kenneth Tiong Boon Kiat
MP for Aljunied GRC

Question No. 1618
To ask the Coordinating Minister for Social Policies and Minister for Health (a) whether the Health Sciences Authority's (HSA) expedited and abridged registration routes apply to medicines approved by China's National Medical Products Administration (NMPA) and not by any of HSA's six drug regulatory reference agencies; (b) given that those agencies were justified as receiving first-wave filings, how will HSA ensure timely access to innovative therapies approved in China; and (c) whether NMPA will be assessed for recognition as a reference agency.

Answer

1        HSA welcomes drug producers to choose Singapore as part of their first wave filings.  As long as a pharmaceutical product is approved by at least one regulatory agency, such as China’s NMPA, it would also qualify for the abridged route. Life-saving innovative therapies that address critical public health needs in Singapore, such as cancer or infectious diseases, will also qualify for priority review by HSA. Regardless of where the drug is developed, we would apply the same rigor in our evaluation. 

2        Specifically on NMPA, HSA has been deepening our engagement, including signing a renewed Memorandum of Understanding in May 2026, to explore facilitative regulatory pathways and pilot innovative initiatives to bring safe and effective products to patients more quickly.