Singapore’s HSA is acknowledged by WHO as a Stringent Regulatory Authority (SRA) for Class C and D IVD for their commitment to applying stringent standards for quality, safety, and efficacy in their process of regulatory review of health products for marketing authorization. This achievement validates HAS’s competency to apply stringent standards for quality, safety, and efficacy. This status is beneficial for manufacturers since IVD products registered with HSA will be qualified for abridged prequalification assessment by WHO which also opens a wider market for manufacturers as major international purchasers such as United Nations Agencies who rely on the listing by the WHO Prequalification Programme.
WHO prequalification is intended to promote and facilitate equitable access to safe, appropriate, and affordable IVDs especially for priority diseases (e.g., human immunodeficiency virus, Ebola, and human papillomavirus), ensuring good quality in an equitable manner globally.
HSA is the sixth authority to receive recognition as SRA, the first authority outside the five founding members (European Union, United States, Canada, Australia, and Japan) of the Global Harmonization Task Force (GHTF). In January 2022, HSA was also awarded WHO Maturity Level 4 (ML4) status for its advanced medicines regulatory system, the highest level of achievement for a national regulatory agency for medicines regulatory excellence.