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Adverse event reporting of therapeutic products

Therapeutic product importers, manufacturers, suppliers and registrants are required to report all serious adverse events of their products.

What to report

It is mandatory for companies to report all serious adverse events. This allows us to continuously monitor the incidence of the adverse events (AEs) locally and assess if there is a safety concern. Additionally, products in the same therapeutic class can be compared to assess their relative safety. 

Note: Serious adverse events caused by accidental or deliberate overdoses and medication errors need not be reported.

The minimum information required for the submission of your initial report is:

  • An identifiable reporter or healthcare professional.
  • An identifiable patient.
  • An adverse effect.
  • A suspected product.

Refer to our guides if you are reporting an adverse event:

How to report

To report adverse events, companies may:

When to report

You should report the AEs as soon as you are made aware of it and adhere to the reporting timelines below. The initial report of an adverse event should contain as much detail as available, but should not be delayed for the sake of gathering more information.

The clock for reporting starts as soon as any personnel in your company, including sales representatives, are made aware of the serious AE. If there is uncertainty about whether the serious adverse event is reportable, you should still submit a report within the time frame stated.

Adverse events reports Report as soon as possible and no later than  
Initial reports of serious adverse events. 15 calendar days
Follow-up reports when additional medically relevant information is received for a previously reported case.

Note: Indicate that it is a follow-up report and link it to the original report.
15 calendar days

Specific adverse events reporting

Reports on local non-serious AEs or overseas AEs

Local non-serious AEs and overseas AE reports occurring outside of Singapore need not be reported to us. However, records of the events must be maintained and made available upon request.

Reports from consumers

Consumers who report AEs should be encouraged to seek medical attention and get the attending healthcare professional to report the AE. Medical confirmation is strongly encouraged for the purpose of submission to our Vigilance and Compliance Branch.

If a consumer is unwilling or unable to seek medical attention, the company should attempt to obtain as much information as possible from the consumer about the AE.

For serious adverse reactions (SAR), voluntary informed consent must be obtained from the consumer before the company contacts the treating healthcare professional for relevant information, such as medical documentation. This is to facilitate causality assessment of such reports by the company. 

Scientific literature & other post-marketing safety information

Any scientific / medical literature or information from unpublished / published study reports, surveys and registries that could change the benefit-risk balance of the registered therapeutic product must be communicated to our Vigilance and Compliance Branch within 15 calendar days after first knowledge. A copy of the relevant report should be provided. If the report is not in English, the company must submit a summary or translation in English.

Reports on AEs of therapeutic products pending registration applications

Where a therapeutic product registration application is pending our review, the applicant must ensure that any new safety information which may impact the benefit-risk balance of the product is immediately submitted to our Therapeutic Products Branch. The applicant is to submit a tabulation of the new or unexpected serious adverse reactions (SAR) that have not been previously submitted and are not mentioned in the proposed Singapore package insert.

The new information may include but are not limited to the following examples:

  • Safety reports of unexpected or new SAR with evidence of causal relationship.
  • Safety reports where there is suspicion of a change in the frequency or severity of a known effect.
  • Results from studies which may negatively impact the efficacy of the therapeutic product.     

Reports on AEs of unregistered therapeutic products

Importers of unregistered therapeutic products for patients’ use must report all suspected cases of local serious adverse reactions (SAR) to our Vigilance and Compliance Branch if the information is made available to them.

They should also follow the requirements on maintaining records of AEs, reporting of AEs in special situations and informing on regulatory actions arising from significant safety issues of the therapeutic product.

It should be indicated that the suspected therapeutic product reported is not registered in Singapore. 

Reporting lack of efficacy of a therapeutic product

The following events should be reported when:

  • The therapeutic product fails to produce the expected pharmacological or therapeutic benefit, and results in an adverse outcome for the patient.
  • The condition for which the medication is being taken worsens.

Some examples of classes of therapeutic products where lack of efficacy must be reported are:

  • Those that are used for the treatment of life threatening or serious diseases.
  • Vaccines.
  • Contraceptives.

Clinical judgment should be used when reporting the event, taking into consideration the local product labelling and disease being treated. 

Reporting outcomes of use during pregnancy

The company should follow up with the doctor if they know that a pregnant woman has consumed a product that is not recommended during pregnancy.

If the pregnancy results in an abnormal outcome and the reporting doctor considers that it might have been due to the product, the company must submit the serious adverse reaction (SAR) report within 15 calendar days upon first knowledge. 

Refer to our Guidance for Industry- Post-Marketing Vigilance Requirements for Therapeutic Products for full details on our safety reporting requirements.