Certificate of a Pharmaceutical Product

Find out how you can apply for the CPP for a cell, tissue or gene therapy product (CTGTP).

Overview

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:

  • Information on whether or not a product is sold in Singapore.
  • Details of the manufacturing site.
  • Product details, such as the formulation.

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.

Registered CTGTP

You will need to submit the following documents:

Unregistered CTGTP made for export only or under product evaluation

You will need to submit the following documents:

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your application through the relevant application form. Ensure you have the following before submitting your application: