The Singapore Health Sciences Authority (HSA) has issued guidance defining therapeutic products, outlining application requirements, and providing classification criteria for Prescription-Only Medicines, Pharmacy Medicines, and General Sales List products.
Key areas covered include patent declarations, data protection and exclusivity provisions, and the complete registration process—from pre-submission engagement to post-approval changes. Applicants and registrants are responsible for ensuring compliance with safety, efficacy, and quality standards, with opportunities for pre-submission consultations to support regulatory adherence.