Find out how you can apply for the CPP for a cell, tissue or gene therapy product (CTGTP).
A Certificate of Pharmaceutical Product (CPP) is a certificate issued in the format as recommended by the World Health Organisation (WHO). It is a document that is internationally recognized by national drug regulatory authorities for establishing the status of a pharmaceutical product under a national product licensing system.
A CPP for CTGTP may be issued for a registered CTGTP, or a CTGTP which is undergoing product registration. The CTGTP must be produced under the required Good Manufacturing Practice (GMP) standards.
The CPP is specific for one product as well as one country of import. Among other information, the certificate includes:
With effect from 1 June 2025, HSA will no longer issue hard copy certificates for CPP. Instead, verifiable electronic certificates will be issued via GovTech’s TrustDocs digital platform. There will not be any changes to the application process, regulatory requirements and application fees for these certificates. For further information, please refer to our Frequently Asked Questions.
You will need to submit the following documents:
Refer to CTGTP fees and turnaround time for more information.
Submit your application through the relevant application form. Ensure you have the following before submitting your application:
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