When the Singapore reference product (SRP) is no longer registered or marketed (in any strength)
We are planning to submit a generic version of X but the original Singapore Reference Product is de-registered. Which of the currently registered products should be the SRP?
If a reference product (innovator) is not available, an alternate registered comparator product may be used if adequately justified (e.g. a registered generic therapeutic product widely used by local hospitals) by the applicant. The acceptability of the justification will be determined during the screening stage of the application. HSA does not provide confirmatory advice on the choice of a specific SRP prior to application submission. You may refer to Sections 16.1 and 16.2 of the Guidance on Therapeutic Product Registration in Singapore for more information on Singapore Reference Product.
We're planning to submit GDA-1 application for product C. However, the originator product is no longer registered and now there are only several generics registered. The reference product that we used in product development and in the BE study is the originator product sourced overseas. Kindly advise if we can use the existing BE study supplemented with comparative dissolution studies conducted between one of the currently registered products in Singapore against the BE reference product.
The BE study performed between the proposed generic and the originator product from overseas can be accepted. In this case, comparative dissolution studies should be provided between the BE reference product and one of the registered generic products in Singapore. Justifications for your choice of the registered generic used in the comparative dissolution studies should be provided. You should also indicate this generic as the alternate SRP in your PRISM application.
Please refer to Appendix 10 Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications for information regarding BE study and comparative dissolution profile testing requirements for GDAs.
Please note that the final acceptability of the BE study can only be determined during screening and/or evaluation of the GDA when the complete dataset is received and reviewed.
Our company’s product’s dossier was compiled based on the reference product: X Tablet 1mg (SIN12345P) which was verified as a registered therapeutic product during the start of the dossier compilation. However, we notice that this product has been removed from the HSA registered TP database and we were planning to submit the GDA soon. Kindly clarify if we are able to proceed with the GDA with X Tablet 1mg (SIN12345P) as the Singapore Reference Product.
We can consider X Tablet 1mg as the Singapore Reference Product for your GDA application as long as the application is filed within 1 year of its removal from the Register of Therapeutic Products. HSA does not provide confirmatory advice on the choice of a specific SRP prior to application submission.
My company is interested to register generic DRUG X Tablet 5 mg. However, based on the current local market surveys, the SRP is no longer marketed in Singapore. Hence, please advise on the appropriate reference product in this situation.
If you are unable to procure the SRP locally for the necessary studies although it is still registered, you may source the SRP-equivalent from overseas markets, i.e. manufactured at the same drug product manufacturing site as the SRP.