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 (AEs). This includes reports where the company does not agree with the reporting healthcare professional's assessment and reports where the healthcare professional has not provided a causality assessment. Serious AEs which are not suspected of being product-related by the healthcare professional should not be reported unless the company has reasons to suspect a causal association.
Note: Serious AEs 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 AE.
- A suspected product.
Refer to our guides if you are reporting an AE:
How to report
To report serious AEs, companies are to complete the Council for International Organisations of Medical Sciences (CIOMS) I form and send it to HSA via one of the following methods:
When to report
You should report the serious AEs as soon as you are made aware of them and adhere to the reporting timelines below. The initial report of a serious AE 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 AE is reportable, you should still submit a report within the time frame stated.
|Adverse event reports
|| Report as soon as possible and no later than
| Initial reports of serious AEs.
||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
Local non-serious AEs or overseas AEs
Local non-serious AEs or overseas AEs occurring outside of Singapore need not be reported to HSA. However, records of the events must be maintained and made available upon request.
Reporting by 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 AEs, 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 and other post-marketing safety information
Any scientific or medical literature or information from unpublished or published study reports, surveys and registries that could change the benefit-risk balance of the 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.
New safety information for therapeutic products pending HSA's review
Where a therapeutic product registration application is pending HSA's 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 AEs 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 serious AEs 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 product.
AEs of unregistered products imported via Special Access Route (SAR)
Importers of unregistered products for named patients’ use must report all suspected cases of local serious AEs to our Vigilance and Compliance Branch.
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 associated with the product.
It should be indicated that the suspected product reported is not registered in Singapore.
Lack of efficacy of a product
The following events should be reported when:
- The 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.
Clinical judgment should be used when reporting the event, taking into consideration the local product labelling and disease being treated.
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.
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 AE report within 15 calendar days upon first knowledge.
Guide for the industry
Refer to our
Guidance for Industry- Post-Marketing Vigilance Requirements for Therapeutic Products
for full details on our safety reporting requirements.