TPs, CTGTPs and MPs

As there is limited safety information available for new treatments, it is important for local sponsors to report new safety information in a timely manner to us.

What to report

Unexpected serious adverse drug reactions (USADRs) should be reported to us in an expedited manner.

USADR refers to a serious adverse reaction arising from a therapeutic product (TP), cell, tissue or gene therapy product (CTGTP) or medicinal product (MP), in which its nature and severity is not consistent with the applicable product reference. The product reference can be the local product information leaflet (for products approved for marketing) or the Investigator's Brochure (for unregistered products).

Different reporting requirements apply, depending on the registration status of the product and how the product is used in the clinical trial: 

When to report

All USADRs should be submitted within a prescribed time from the local sponsor’s date of awareness.

For fatal or life-threatening USADRs, local sponsors must submit the initial report as soon as possible and no later than 7 calendar days, with the next follow-up report within 8 calendar days of the initial report. Subsequent follow-up reports should be submitted in a timely manner as they become available.

For other USADRs, local sponsors must submit the initial report as soon as possible and no later than 15 calendar days. Subsequent follow-up reports are to be submitted in a timely manner as they become available.

Minimum criteria for reporting

Initial reports should be submitted within the prescribed time as long as the following minimum criteria are met:

• An identifiable patient
• A suspect therapeutic or medicinal product
• An identifiable reporting source
• Event or outcome that can be identified as serious and unexpected
• A reasonable suspected causal relationship

When to start and stop submitting safety reports

Submission of USADRs should start immediately upon clinical trial authorisation, acceptance of notification or issuance of a clinical trial certificate.

However, should any new safety concerns surface from individual reports or aggregate analysis of USADR during the clinical trial application review period, local sponsors should ensure that the new safety information is promptly communicated to us via email, so that the information can be considered in the benefit-risk assessment of the clinical trial.

Submission of USADRs may stop when the Last Patient Last Visit (LPLV) is achieved in Singapore, unless otherwise indicated in the protocol. However, local sponsor should inform us of any new safety information that emerges thereafter, particularly if the information is of relevance or potential significance to previously-treated trial participants. 

How to report

You may report the USADR to us using CIOMS-I form (view sample form in our guidance538 KB).

It is recommended that the description for the USADRs be reported using Medical Dictionary for Regulatory Activities (MedDRA).

For regulated clinical trials, the safety reports should be submitted through the Expedited Safety Reporting (ESR) online module in PRISM. Ensure you have the following credentials before you access the e-service:

• CRIS company account
• Corppass or HSA PIN 

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

For clinical trials not regulated by us, the safety reports should be submitted via e-mail to us.

Refer to our Guidance on Expedited Safety Reporting Requirements for Clinical Trials538 KB for full details on our safety reporting requirements. 

Medical devices

To achieve the objective of protecting health and safety of patients, users and others in clinical trials, safety issues associated with medical devices should be identified as soon as possible.

These issues can then be addressed through modifications of medical device or clinical trial protocol, revision of the instructions for use, or withdrawal of the device from use.

Refer to GN-05: Guidance on Reporting of Adverse Events for Medical Devices for full details on adverse events reporting requirements.

What to report

As a general principle, you should be pre-disposed to report a medical device adverse event (AE). Any AE that meets the criteria listed below is considered reportable:

1. An AE (or potential AE) has occurred.
2. The device product is associated with the AE.
3. The AE led to one of the following outcomes:
   • A serious threat to public health.
   • Serious deterioration in state of health of patient, user or other person.
   • No death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other person if the event recurs.
   • Death of a patient, user or other person.

When to report

The following AEs must be reported to us within the indicated timelines:

The reporter should include as much relevant detail in the initial report as is immediately available, and should not delay the report for the sake of gathering additional information.

The sponsor of the medical device clinical trial should follow up with a final report within 30 days of the initial report, detailing the investigation into the AE. Follow up reports may be requested as and when necessary.

How to report

It is mandatory for local sponsors and medical device companies (including product registrants, manufacturers, importers and suppliers) to report any AEs related to the medical devices they deal in.

Please complete the Medical Device Adverse Event Report Form for Clinical Trials174 KB and submit to us via e-mail with the subject as "Medical Device AE Reporting for Clinical Trials".