Biologics analysis

Find out more about our services and how you can submit your biologics product samples to our Biologics Laboratory for testing.

Scope of services  

  • Laboratory Testing of Biologics Products

    For the details of the tests offered in our services, please send enquiries to HSA_PD_Enquiry@hsa.gov.sg.

  • Product Quality Surveillance (PQS)

    Biologics products that are released in our local market are periodically sampled and tested for quality and safety to safeguard public health.

  • Investigative Studies

    Independent testing will be conducted during investigations into cases such as serious adverse events related to the use of substandard biologics products to support enforcement actions taken by regulatory departments.

  • Vaccine Quality Assurance

    Ensuring the quality of vaccines is crucial as they are typically used in our healthy populations. Our laboratory assures the quality of vaccines by conducting lot release of locally manufactured vaccines and administering the notification programme of imported vaccines. 
  •   Lot release of locally manufactured vaccines

The laboratory administers lot release of locally manufactured vaccines by providing scientific review of manufacturers' summary protocols in collaboration with the Health Products Regulation Group (HPRG) at HSA, and laboratory testing.

For more information on lot release of locally manufactured vaccines, please contact us at  HSA_PD_Enquiry@hsa.gov.sg, and submit requests for lot release via this Form.

  •   Notification of imported vaccines for local supply

It is required for product registrants to notify HSA on the lot release information of registered vaccines imported for local use. Our laboratory administers this notification programme and verifies the submitted lot release information of these imported vaccines.

Please refer to our notification webpage for more information and submit the notification via this Form.

 

For other enquiries about the Biologics Laboratory services, please contact us at HSA_PD_Enquiry@hsa.gov.sg.