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)

Login to  SHARE for the following: 

  • Submit new or update CTGTP notification
  • Update contact details through the Company Address Book

*Note: For changes in company’s name or business address (without changes in company’s Unique Entity Number; UEN), please make the changes through the Accounting and Corporate Regulatory Authority (ACRA). After these changes are approved by ACRA, the information will be synchronised in SHARE upon your next login.

The company’s UEN issued by ACRA is a unique identification number assigned to entities registered in Singapore. If your company is operating under a new UEN (new entity registered with ACRA), you will need to apply for new licences and certificates with HSA, if these are required under the new entity. HSA licences and certificates cannot be transferred from one UEN to another UEN.

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]
    • Update contact details through the Company Address Book

    *Note: For changes in company’s name or business address (without changes in company’s Unique Entity Number; UEN), please make the changes through the Accounting and Corporate Regulatory Authority (ACRA). After these changes are approved by ACRA, the information will be synchronised in SHARE upon your next login.

    The company’s UEN issued by ACRA is a unique identification number assigned to entities registered in Singapore. If your company is operating under a new UEN (new entity registered with ACRA), you will need to apply for new licences and certificates with HSA, if these are required under the new entity. HSA licences and certificates cannot be transferred from one UEN to another UEN.

    Useful links:

    Special Access Route (SAR)

    How to apply

    1. Ensure that you have the following:
      • CRIS company account and note your client code for billing
      • Corppass
    2. Complete the relevant request form below digitally and save a copy:
    3. Complete and submit the relevant online application FormSG below:
    4. 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. 

    Withdraw application

    Complete and submit the  SAR application withdrawal form.

    Changes to business or applicant details

    The company’s Unique Entity Number (UEN) issued by Accounting and Corporate Regulatory Authority (ACRA) is a unique identification number assigned to entities registered in Singapore. If your company is operating under a new UEN (new entity registered with ACRA), you will need to apply for new licences and certificates with HSA, if these are required under the new entity. HSA licences and certificates cannot be transferred from one UEN to another UEN.

    For changes in company's registered name and business address (without changes in UEN), please inform HSA in writing to HSA_CTGTP@hsa.gov.sg and update the changes via the e-service Change of Business Information.

    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:

    Dealer's licence or certificate

    Login to SHARE for the following:

    • Apply/Amend/Cancel CTGTP Dealer's Licence 
    • Apply CTGTP Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) Certificates 
    • Track/withdraw applications
    • Check active CTGTP dealer's licences and certificates
    • Update contact details through the Company Address Book

    *Note: For changes in company’s name or business address (without changes in company’s Unique Entity Number; UEN), please make the changes through the Accounting and Corporate Regulatory Authority (ACRA). After these changes are approved by ACRA, the information will be synchronised in SHARE upon your next login.

    The company’s UEN issued by ACRA is a unique identification number assigned to entities registered in Singapore. If your company is operating under a new UEN (new entity registered with ACRA), you will need to apply for new licences and certificates with HSA, if these are required under the new entity. HSA licences and certificates cannot be transferred from one UEN to another UEN.

    Useful links:

    Certificate of CTGTP intended for export

    Apply for a Certificate of a Pharmaceutical Product (CPP) or Certificate of Free Sale (FSC)

    1. Ensure that you have the following:
      • CRIS company account and note your client code for billing
      • Corppass
    2. Complete the application form digitally and save a copy for your reference:
    3. Attach your PDF and submit your application via CTGTP Dealer's Submission.

    4. 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 CPP or FSC application

    Submit your 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:

    • Certificate not applicable or not required
    • Change of business decision
    • Duplicate application

    Changes to business or applicant details

    The company’s Unique Entity Number (UEN) issued by Accounting and Corporate Regulatory Authority (ACRA) is a unique identification number assigned to entities registered in Singapore. If your company is operating under a new UEN (new entity registered with ACRA), you will need to apply for new licences and certificates with HSA, if these are required under the new entity. HSA licences and certificates cannot be transferred from one UEN to another UEN.

    For changes in company's registered name and business address (without changes in UEN), please inform HSA in writing to HSA_ALD_Appl@hsa.gov.sg and update the changes via the e-service Change of Business Information.