Application process
If you are an importer of Clinical Research Material (CRM), you will need to submit a CRM notification before importing the CRM, unless the CRM is locally-registered and you are the licensed importer for the locally-registered product.
If you are a local manufacturer who will be supplying self-manufactured CRM for use in local clinical research, you will need to submit CRM notification before supplying the CRM, unless the CRM is locally-registered and you are the manufacturer and the supplier of the locally-registered product.
There are no fees involved for the CRM notification.
For clinical trials regulated by us
If CRM notification is required, the local sponsor will submit the CRM notification on behalf of the importer or local manufacturer, along with the clinical trial application, in accordance with the steps below:
- Local sponsor drafts application for Clinical Trial Authorisation/ Notification/ Certificate (CTA/CTN/CTC), which includes a section for CRM notification.
- Local sponsor notifies the CRM importer or local manufacturer to endorse the CRM notification section in CTA/CTN/CTC application draft.
- CRM importer or local manufacturer endorses CRM notification section in CTA/CTN/CTC application draft.
- Local sponsor submits CTA/CTN/CTC application to us.
Note: The quantity of CRM to be imported or supplied should be provided based on the actual or a realistic estimate of the quantity required for the trial protocol and the defined sample size.
Upon successful submission of the CTA/CTN/CTC application, the CRM importer or local manufacturer and local sponsor will receive an email acknowledgement from us. Upon receipt of this acknowledgement, the CRM importer or local manufacturer may proceed to import or supply the CRM respectively.
The CRM notification will remain valid for the duration of the clinical trial.
Refer to CTA, CTN or CTC submissions for details.
For clinical trials not regulated by us, such as medical device clinical trials
If CRM notification is required, the CRM importer or local manufacturer will submit the CRM notification in accordance with the steps below:
- CRM importer or local manufacturer makes a CRM notification application draft.
- CRM importer or local manufacturer notifies the local sponsor to endorse the application draft.
- Local sponsor endorses CRM notification application draft.
- CRM importer or local manufacturer submits CRM notification to us.
Note: The quantity of CRM to be imported or supplied should be provided based on the actual or a realistic estimate of the quantity required for the research protocol and the defined sample size.
Upon successful submission of the CRM notification, the CRM importer or local manufacturer and local sponsor will receive an email acknowledgement from us. Upon receipt of this acknowledgement, the CRM importer or local manufacturer may proceed to import or supply the CRM respectively.
The CRM notification will remain valid for one year from the date of notification, and may be extended or amended through PRISM. The CRM importer or local manufacturer must ensure that the CRM notification remains valid when the CRM is being imported or supplied for the clinical research study.
The CRM importer or local manufacturer may cancel the CRM notification if the CRM is eventually not imported or supplied.
Please refer to our Guidance on CRM783 KB for more details.
Documents required
You will need the following documents before submitting a CRM notification, if applicable:
- List of components in a medical device system
- Packing list for study-visit specific lab kits, if products in lab kits are not declared in the application form
How to submit a CRM notification
You will need to submit your CRM notification through PRISM (view sample online form294 KB). Refer to our training slides on CRM notification1938 KB for more details.
Ensure you have the following credentials before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).
You may amend, extend or cancel your CRM notification through PRISM.
To report CRM notification related non-compliances, please submit a CRM Non-Compliance Form.
For submission of CRM notification for regulated clinical trials, please refer to CTA, CTN or CTC submissions for details.