In the past, API regulations in Singapore have been governed by the Poisons Act 1938 and the Medicines Act 1975. Under the Medicines Act, wholesalers and importers of APIs are recommended to apply for GMP certification, and under the Poisons Act, they need to be licensed. Singapore’s HSA now plans to replace these Acts with new legislation for APIs called the Health Products Act (HPA).
The reason for the new Act is to make API manufacturers wholesalers and importers improve their overall quality. One of the goals of this act is to align Singapore’s API regulations more closely with international API standards. Companies in Singapore in the API business will now be inspected and need to meet with either the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), GMP regulations, or Singapore’s Good Distribution Practices (GDP). The HSA invites API participants’ feedback on this new regulation up until August 17, 2023.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.