Singapore HSA Guidance: Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs in 2026

Sharan Murugan
Apr 30
3 min read

The Singapore Health Sciences Authority (HSA) has released Version 6 of its updated guidance document titled “Post-Marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP)”, effective from 1 April 2026. The updated guidance provides important clarification on pharmacovigilance obligations, adverse event reporting, risk management plans (RMPs), and post-registration safety responsibilities for companies operating in Singapore’s life sciences sector.

Scope:

The guidance applies to:

Registrants, manufacturers, importers, and suppliers of registered therapeutic products and CTGTPs in Singapore
Importers of unregistered therapeutic products and CTGTPs supplied for named-patient use
Companies responsible for post-marketing safety monitoring and compliance activities

Key 2026 Updates

Version 6 of the guidance introduces several important updates to Singapore’s pharmacovigilance requirements. These include:

Clarification of scope and marketing status requirements
Updated reporting criteria for serious adverse events
Distinction between spontaneous and solicited reports
Additional examples for identifiable patient information
Revised literature reporting requirements
Updated lack-of-efficacy reporting criteria
Inclusion of eCTD as an alternative submission platform for therapeutic products
Revised submission methods for RMP-related documents

Serious Adverse Event Reporting

The guidance states that companies must report any serious adverse event (SAE) to HSA within 15 calendar days after first becoming aware of the event. This requirement applies to both spontaneous and solicited reports. The company must also perform and document a causality assessment explaining the relationship between the product and the reported adverse event.

Follow-Up Reporting and Record Retention

When new medically relevant information becomes available for a previously reported case, companies must submit follow-up reports within another 15 calendar days. These records must be retained for at least two years after the product expiry date to support traceability and regulatory inspections.

Consumer Reports and Scientific Literature

HSA strongly encourages medical confirmation for adverse events reported directly by consumers. Companies should collect sufficient information to support causality assessment whenever possible. The guidance also requires companies to report local serious adverse events identified through scientific literature if patient-identifiable information is available. Relevant literature articles or abstracts must be submitted as part of the report.

For gene therapy products and other CTGTPs, HSA may require long-term safety monitoring for delayed adverse events such as insertional mutagenesis or secondary malignancies. Long-term follow-up may extend up to 15 years depending on the product risk profile. The guidance outlines both routine and additional risk minimisation activities (RMA).These measures are designed to improve awareness of important safety risks and reduce the likelihood of adverse outcomes.

Periodic Benefit-Risk Evaluation Reports (PBRERs)

HSA may request routine or ad hoc submission of PBRERs for selected products. These reports provide a comprehensive analysis of emerging safety and benefit-risk information.

The standard submission schedule includes:

Every 6 months for the first 2 years after approval
Annually for the following 3 years

Additional submissions may be requested when significant safety concerns arise.

Safety Notifications and Regulatory Actions

Registrants must notify HSA whenever major safety-related regulatory actions are taken internationally.

The guidance specifically references regulatory actions taken by agencies such as:

FDA
EMA
MHRA
TGA
Health Canada
Swissmedic

Companies must also provide local impact assessments and proposed follow-up actions for Singapore.

The guidance also reflects increasing regulatory attention toward advanced therapies such as gene therapy products, where long-term safety monitoring and enhanced pharmacovigilance are becoming increasingly important.