Updated on 28 September 2012
Can the Merlion help you to get regulatory clearance in Singapore?
The sector of life sciences in the Asia Pacific (APAC) region offers massive opportunities for companies, which are looking for growth. These firms often face many regulatory challenges in the APAC region.
BioSpectrum speaks to industry individuals and regulatory professionals from Singapore, in order to compile a guide on the regulatory processes in the country. (Also read during this week: Regulatory requirements in China, Taiwan, Australia, Hong Kong, India, Indonesia and Korea)
In Singapore, pharmaceuticals, biologics, medical devices and health-related products are regulated by Health Products Regulation Group, a division of Health Sciences Authority.
How to register a new drug in Singapore
If the application is yet to be approved by any regulatory agency, a full dossier has to be submitted to the Health Sciences Authority (HSA) for regulatory decision. It takes around 270 working days.
If the application is approved by one drug regulatory agency, an abridged dossier has to be submitted for abridged evaluation and regulatory decision. It takes around 180 working days.