Pharmaceutical/Drug Registration in Singapore

Singapore's pharmaceutical market is about $500 million. It is also the wealthiest country in the Association of Southeast Asian Nations (ASEAN).

All pharmaceuticals/drugs require a product license before they can be imported or sold in Singapore. In applying for a product license, dossiers must be in either the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format or the ASEAN Common Technical Document (ACTD) format.

For new product licenses, Singapore has a new drug application (NDA) and a generic drug application (GDA). For products already approved by certain regulatory agencies (such as Australia's TGA, the US FDA, etc.), submitting an abridged dossier is possible. Applicants submit an online application through PRISM (Pharmaceutical Regulatory and Information System) and also submit a CTD dossier.

For more information on pharmaceutical/drug registration in Singapore, please see the following PBM publications and/or contact us to discuss your specific needs.

Singapore's Pharmaceutical and Medical Device Regulatory Environment: 2005 Update