Singapore

Pharmacovigilance in Singapore is regulated by the Health Sciences Authority (HSA). Therapeutic-product registrants and relevant dealers must maintain effective safety-monitoring arrangements and report local serious adverse events as soon as possible and no later than 15 calendar days. RMPs are product- and risk-based; significant safety issues must be notified promptly, while PBRER submission is generally upon HSA request. HSA does not impose an EU-style QPPV or PSMF as a universal named requirement, so those terms are not universal named requirements. Where the cited public sources do not expressly define signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.