Health Sciences Authority (HSA) updated its "GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE" recently, which describes the procedures and requirements for submitting an application to register a therapeutic product or to make a variation application to a registered therapeutic product..
This guidance document outlines the regulatory processes and requirements for Therapeutic Product registration.
The Health Products Act (HPA) provides the legislative basis for regulating the manufacture, import, supply, presentation, and advertisement of therapeutic products, one of the health products categories regulated under the Act.
The applicant is responsible for submitting the application and all the accompanying supporting documents (including but not limited to the dossier, responses to HSA’s queries and commitment letters).
Applicants are advised to check HSA's website for the latest version of this guidance document and other related therapeutic product registration guidelines.
Click this LINK to know more about this guideline.
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