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)

    Login to SHARE for the following:

    • SAR (Unregistered CTGTP) Application
    • SAR (Registered CTGTP) Application
    • Withdraw an SAR Application
    • 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:

    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 a Pharmaceutical Product (CPP) or Free Sale Certificate (FSC)

    Login to SHARE for the following:

    • Apply for CTGTP CPP or FSC
    • Track/withdraw applications
    • View and download 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.