Singapore: HSA Updates on the Therapeutic Product Registration Guidance

ARQon
Jul 12, 2023
2 min read

HSA revises the regulatory requirement and process for Therapeutic Products Registration and updates the guidance for the industry. As of 30 June 2023, the guidance updates covered are:

Guidance on Therapeutic Product Registration in Singapore
Import and supply Registered Therapeutic Products on Consignment Basis
PRISM Submission guideline

The biosimilar labelling regulations no longer include the obligatory requirement to include a warning statement about the risk of switching medicines while receiving treatment. This elimination was done after taking into account the fact that both reference and biosimilar products underwent clinical comparability demonstration to generate valid comparison data for both products.

Next, product registrants are reminded to comply with new updates for the proposed labelling for variation applications. Product registrants must verify all information stated in currently approved labelling and any proposed labelling changes must be properly annotated. Any inappropriately annotated labelling may lead to application withdrawal. This requirement is cited in Sections 24.2.1 and 27.

HSA also revised the Category A3 patent declaration form by defining the pre-specified condition for the application. For Form 1 in Appendix 1, Category A patent declaration can only be applied by any application with 18 months of patent expiry from the application submission date. While Form 2 in Appendix 1, the form now must be stated with the name of the company and authorized person for clarification. The updated form will be effective from 31 July 2023.

Another online form update effective from 31 July 2023 is the notification form for Drug Master File (DMF) submission. DMF holders may submit the Letter of Access for existing DMF through the new online form. The revised version of the online form is expected to increase efficiency and fewer processing steps needed by the DMF holders.

Lastly, there are 6 new options for manufacturing operations added to Section 5 - Manufacturer’s Particulars in the PRISM application form. Starting from 30 June 2023, all the new operation selections are applicable for new and variation applications.