There are 3 possible routes for approval of Western Medicinal Products:

1. Full evaluation-  A full dossier is required when the product is not registered anywhere in the world. This route is only applicable to NDAs ie where the active ingredient has not been registered in Singapore before.
2. Abridged route- An abridged dossier may be submitted based on registration in another country.
3. Verification route:  A dossier for an NDA may be submitted based on registration with selected benchmark agencies.

All Applications need to fulfill the dataset specifications for each route.

• Documents may vary depending on whether the product is a generic or an NCE.  Guidance documents and checklist on the HSA website indicate what documents are needed for each kind of application.
• Dossiers can be compiled in either the ACTD or ICH CTD format.
• Fees payable are listed on the HSA website.

To submit an application, an online application form must be completed and submitted, together with the supporting documents.

HPPC has extensive experience in compiling and submitting dossiers. Contact HPPC for professional advice.