Updated on 5 July 2012
Post marketing surveillance includes safety vigilance and risk-benefit assessments of marketed health products; risk communication and provision of unbiased information to healthcare professionals and consumers; quality surveillance and compliance monitoring of marketed health products; and investigation and enforcement of legislation and prosecution of offenders.
The HSA also conducts inspections to check compliance with pre- and post market good manufacturing practises, licensing of manufacturers, good distribution practises and licensing of importers and wholesalers.
Is Singapore exposed to generic drugs? How can a generic drug developer access the Singapore market?
Since it is a well-known fact that the pipeline for innovative drugs is drying up, Singapore is open to generics drugs from all companies and countries as long as they meet the safety criteria. To enter the Singapore market, if the drug is already approved by one international drug regulatory agency, an abridged dossier has to be provided to the HSA for abridged evaluation and regulatory decision. This takes 240 working days. If the product is approved by reference regulatory agency that includes the US Food and Drug Administration, Health Canada, UK Medicines and Healthcare Products Regulatory Agency, Australia Therapeutic Goods Administration and European Medicines Agency, a company has to provide just the verification dossier for the evaluation based on assessment report by reference regulatory agency and regulatory decision. In this case, it takes 120 working days.
Singapore's generic drugs are manufactured in different parts of the world. Based on our registration data from 2010 to 2012, more than 50 percent of generic drugs are manufactured in Europe and the other top three countries are India, the US and Malaysia.
What is the status of approval of generic drugs against new drugs in Singapore?