Compliance with the manufacturing and regulatory requirements
Prior to submitting the application, you should ensure that you comply with the principles and guidelines specified in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, including appointment of suitable responsible persons for production and quality operations.
HSA would normally assess the manufacturer’s compliance through an on-site inspection.
For new licence application, the assigned inspectors would contact you to arrange for pre-approval inspection within 3 months from the date of application. Following the inspection, you may take some time to provide a satisfactory response to any inspection findings, which could vary from 3 to 12 months.
Once the inspection is satisfactorily closed out, the licence application will be approved in 10 working days from the date of inspection close-out. The manufacturer’s licence is issued electronically in PRISM after approval of the application.
You are advised to consider the timeline involved in the licence application process in your planning and ensure that you are inspection-ready before submitting the application.
If you are considering establishing a new manufacturing site in Singapore, you are encouraged to engage with the HSA at an early stage to facilitate the licence application process. You can reach out to Good Manufacturing Practice Unit via hsa_gmp@hsa.gov.sg.