You must notify HSA before you import, wholesale or manufacture any minimally manipulated CTGTP in Singapore.
Companies dealing in only minimally manipulated CTGTP (e.g. all Class 1 CTGTP) are not subject to licensing requirements. However, these companies will need to notify HSA prior to the start of their manufacturing, importing or wholesaling activity.
Upon successful submission of a notice, the dealer will be considered a known importer, known wholesaler or known manufacturer. Known dealers are required to comply with the respective duties and obligation as stated under the CTGTP regulations such as duties to:
Failure to submit a notice is an offence under the CTGTP Regulations.
Companies dealing in a minimally manipulated CTGTP which is intended for clinical use are required to comply with the quality system standards as follows:
For manufacturers:-
For importers and wholesalers:-
Renewal of the notice is not required. However, the company must submit an update of the dealer’s notice whenever there are any changes to the information (including cessation of business) which was provided earlier in the notice, within 14 days of the change.
Refer to CTGTP fees and turnaround time for more information.
Submit your applications through SHARE.
Regulatory overview
Class 1 CTGTP notification
Register a Class 2 CTGTP
Variation applications
Dealer's notice
Dealer's licensing and certification
Risk management plan requirements
Report adverse events
Report or recall defective products
Clinical trials
Product consultation
Advertisements and promotions
Certificate of a Pharmaceutical Product
Duties And Obligations
Guidance documents
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of CTGTP Dealer's Notices, Licences and Certificates
CTGTP E-services