Singapore Pharmaceutical Registration and Approval

The Singaporean regulator of pharmaceuticals is the Health Sciences Authority (HSA). The Therapeutic Products Division of the HSA is accountable for reviewing and approving pharmaceuticals; their subdivision is the Pharmaceuticals & Biologics Branch.
All drugs require a product license prior to being imported or sold in Singapore. When applying for a product license, dossiers must comply with the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format or the ASEAN Common Technical Document (ACTD) format.

For new product licenses, Singapore requires a new drug application (NDA) and a generic drug application (GDA). For products previously approved by certain regulatory agencies (e.g. Australia’s TGA, US FDA, etc.), submitting an abridged dossier is a possible option. Applicants submit an online application and CTD dossier through PRISM (Pharmaceutical Regulatory and Information System).