Audit and Licensing of Manufacturers
Under the Health Products Act and Medicines Act, all local manufacturing facilities engaged in the manufacture or assembly of therapeutic products and Chinese Proprietary Medicines (CPM) must be licensed with Health Sciences Authority. The manufacturers are expected to comply with the relevant legislative and regulatory requirements, and Good Manufacturing Practice (GMP) standard.
For more information, please click the hyperlinks below:
- Manufacturer’s Licence for Therapeutic Products
- Manufacturer’s Licence for Chinese Proprietary Medicines
- Licence to Manufacture Controlled Drugs
With effect from 1 April 2004, all new overseas manufacturers who intend to register their therapeutic products in Singapore will be subjected to GMP Conformity Assessment.
For more information, please click the hyperlink below:
Target Processing Timeline
- Issuance of new Manufacturer's Licence – 10 working days from date of audit close out (excluding any stop-clock time incurred by the applicant)