Updated on 28 September 2012
If the application is approved by HSA's reference regulatory agencies, which include the US FDA, Health Canada, UK MHRA, Australian TGA and EMEA, a verification dossier has to be submitted for evaluation and regulatory decision based on assessment report by reference regulatory agency. This takes around 60 working days.
How to register a generic drug in Singapore
If the product is approved by one drug regulatory agency, an abridged dossier has to be submitted for abridged evaluation and regulatory decision. It takes 240 working days.
If a product is approved by reference regulatory agencies, verification dossier has to be submitted for evaluation based on assessment report by reference regulatory agency for regulatory decision. It takes around 120 working days.
(As shared by Dr Raymond Chua, group director, Health Products Regulation Group, Health Sciences Authority, Singapore. To know more about regulatory-related issues in Singapore, visit www.hsa.gov.sg)