Please refer to of the Guidance on Therapeutic Product Registration in Singapore (2018) for the requirements for therapeutic product registration.
A company that is registering a therapeutic product, i.e. the applicant, must be a local business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore. Applications must be submitted online via PRISM and the applicant is required to obtain a HSA CRIS account in order to make the submission. Guidance on the submission via PRISM is available here.
The person acting on behalf of the company in submitting the application must be duly authorized by the company CRIS administrator. Information on CRIS can be found here.
For application fees, please click here. For target processing timelines of applications, please click here.