HSA Post-marketing Vigilance Guidance 2026

HSA’s Guidance for Industry — Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP was revised as Version 6 and uploaded on 1 April 2026. It provides general guidance for companies monitoring and reporting safety information after products enter the market; written law takes precedence if there is a contradiction (HSA, 1 Apr 2026).

Main reporting clarifications

Version 6 refines the scope by addressing marketing status, adds point-of-contact details, and updates the criteria for submitting serious adverse events. It distinguishes between spontaneous and solicited reports, adds examples for an identifiable patient, clarifies events outside reporting requirements, and stresses medical confirmation and follow-up for causality assessment of consumer reports. The revision history also says the summary table in Annex I now applies to both solicited and spontaneous reports, while the online reporting form remains unchanged. These changes matter because the reporting source and the submission route are separate questions: a company must first assess whether the case meets the substantive reporting criteria, then use the specified HSA channel and retain the underlying record (HSA, Version 6, 1 Apr 2026).

Efficacy, literature and study-report changes

The revision updates criteria for lack-of-efficacy reports and adverse events arising from literature. It also adds clinical safety study reports to the introductory scope and reorganises the former section 8.5 material into section 8, so the version change is broader than a portal-link update. The guidance separately explains that a lack-of-efficacy report with no associated adverse event should not normally be reported, although the record must still be maintained. For literature cases, a report depends on an identifiable patient and a reasonable possibility of causality where the author's suspicion is not clear; a general statement that several patients experienced an outcome is not enough on its own. The practical question is therefore whether the source contains a reportable case, not simply whether it mentions the product or an unfavourable result (HSA, Version 6, 1 Apr 2026).

Submission-format boundary

Version 6 recognises eCTD as an alternative platform for submitting dossier information in specified sections and updates the Singapore-specific annex and online-reporting references. For example, new safety information affecting the benefit-risk balance of a therapeutic product under review may be uploaded in PRISM or eCTD, while CTGTP information is routed through SHARE and the relevant HSA contact. The platform choice does not change the substantive duty to assess safety information, and it does not turn a dossier submission into an adverse-event report. This guidance concerns safety surveillance and reporting; it does not itself grant marketing authorisation, replace product-registration requirements, or make every adverse event reportable. Written law takes precedence if it conflicts with the guidance, and companies should use the current HSA instructions for the applicable product and submission context (HSA, Version 6, 1 Apr 2026).

Who the guidance covers and what companies must maintain

The guidance applies to registrants, manufacturers, importers and suppliers of registered therapeutic products and cell, tissue or gene therapy products (CTGTP), regardless of the product's local marketing status. It also applies to importers bringing unregistered therapeutic products or CTGTP into Singapore for patients' use. Its population is therefore the companies and importers responsible for these product categories, not every healthcare provider or every consumer who experiences a symptom. The document expects a company to maintain written procedures for receiving and evaluating adverse events, reporting serious adverse events, and responding to HSA safety communications. A company must also provide a safety point of contact who can respond to HSA in a timely way and keep that contact information current. For each event concerning an adverse event from use of the product, the manufacturer, importer, supplier or registrant must retain the product name, the date it first became aware of the event, the lot, batch or serial number, and the nature of the event. HSA says those records must be retained for at least two years after the product's expiry date (HSA, Version 6, 1 Apr 2026).

Serious-adverse-event clock and minimum case information

Companies must report serious adverse events to HSA as soon as possible and no later than 15 calendar days after any company personnel become aware of the event. Version 6 states that this applies to both spontaneous reports, such as direct communications from healthcare professionals or consumers, and solicited reports from clinical trials, non-interventional studies, patient-support programmes or market-research programmes. If the company is uncertain whether an event is reportable, the guidance says it should still submit within the 15-day period. An initial report should contain four minimum elements: an identifiable reporter or healthcare professional, an identifiable patient, an adverse event and a suspected product. HSA gives examples of patient-identifying information such as age or age category, gestational age, sex, initials, date of birth, name or patient-identification number. The company should also explain whether it considers a causal association possible and how it assessed causality. If medically relevant information arrives later for an already reported case, a clearly labelled, cross-referenced follow-up report is due as soon as possible and within 15 calendar days. The deadline is therefore a reporting clock tied to awareness and follow-up information, not a general 15-day deadline for every complaint or non-serious symptom (HSA, Version 6, 1 Apr 2026).

Local, literature and special-situation boundaries

The reporting rule has important boundaries. HSA states that overseas adverse events, off-label-use reports with no associated adverse event, cases containing only an outcome such as death, and local non-serious adverse events generally do not need to be submitted, although records must still be maintained; a cluster of local non-serious events indicating a possible safety issue can change that assessment. Consumer reports should be supported by medical attention and confirmation where possible, but a company should still try to obtain enough information for causality assessment when the consumer cannot or will not seek care. Local serious cases from scientific or medical literature are reportable when patients are identifiable, and the company should provide the relevant literature. Separate duties apply to products pending HSA review: new safety information that may affect the benefit-risk balance must be submitted immediately through the applicable route, including PRISM or eCTD for therapeutic products and SHARE for CTGTP. Importers of unregistered products brought in for named patients must report suspected local serious adverse events when the information becomes available and identify that the product is not registered in Singapore. These distinctions prevent the guidance from being read as either “report every symptom” or “report only events from fully registered products” (HSA, Version 6, 1 Apr 2026).