CTGTP E-services

Submit applications or view cell, tissue and gene therapy products (CTGTP) information online.

Product notification, registration and variation applications

Product notification (new and updates)

Submit your new product notification or update notification through SHARE.

Useful links:

Product registration and variation

    Login to SHARE for the following:

    • New CTGTP Registration (NDA)
    • Major or Minor Variation (MAV-1/MIV-1/MIV-2) Application
    • Withdraw an Application
    • Fulfilment of Approval Conditions
    • Change of Registrant
    • Cancel CTGTP Registration [Note: Cancellation is immediate and irreversible]

    Useful links:

    Special Access Route (SAR)

    How to apply

    1. Complete the relevant request form digitally.
    2. Complete the relevant online application form via the FORMSG link below, attach the completed request form from step 1 and submit the application.
    3. Upon successful submission, an application reference number will be sent to your email. Please cite this reference number for your payment transaction and future enquiries pertaining to the application. 
    4. Submit the supporting document(s) via CD/DVD or email, indicating the product name and application reference number.

    Online application forms (FORMSG links)

    Application Withdrawal

    Dealer's notice, licence and certificate applications

    Dealer's notice (new or changes to dealer's notice)

    Submit your new dealer's notice or update notice through SHARE.

    Useful links: HSA SHARE Applicant User Manual

    How to apply

    1. Complete the application form digitally and save a copy for your reference.
    2. Attach your PDF and submit your application via CTGTP Dealer's Submission.

    3. An acknowledgement email with the application reference number will be sent to your email indicated in your submission. Please cite this reference number in your payment transaction and future enquiries pertaining to the application.

    Withdraw a dealer's application

    You can withdraw your application before it is approved or rejected by submitting a request through CTGTP Dealer’s Submission indicating the reason(s) for the withdrawal.

    A refund of the application fee may not be granted in the case whereby substantial work has already been done in the evaluation/technical assessment of the application.

    Possible reasons for withdrawal include the following:

    • Licence or certificate not applicable or not required
    • Company is not ready for inspection
    • Change of business decision
    • Duplicate application

    Renew a dealers licence

    Submit your dealer's licence renewal application via the CTGTP Dealer’s Submission at least one month before your licence’s expiry date to allow sufficient time for the renewal fee to be cleared for the licence to be renewed.

    Upon successful renewal, the licence will be valid for 12 months from the last licence expiry date.

    Cancel a dealers licence

    Submit your dealer's licence cancellation request via CTGTP Dealer’s Submission.

    Change to business or applicant details

    Please inform HSA by writing in to email at HSA_ALD_Appl@hsa.gov.sg if you have changes in  company’s Accounting and Corporate Regulatory Authority (ACRA) registered name and business address and applicant details. In addition, please use the e-service Change of Business Information to change company particulars such as company’s ACRA registered name and business address, provided there is no change to the company's Unique Entity Number (UEN).

    The company’s UEN, as issued by ACRA, is used as the standard identification of a legal entity. For a change in UEN, the company is considered a new business entity. Licences or certificates issued to the company under the old UEN will not be valid anymore. The company will need to apply for a new CRIS account using the new UEN and thereafter submit new licence or certificate applications if the licence(s) or certificate(s) are required under the new business entity.