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This application is a service of the Singapore Government.

Health Sciences Authority

Chinese Proprietary Medicines

Manufacturer’s Licence for Chinese Proprietary Medicines (CPM)

Regulatory Guidelines and Standards

Since 1996, HSA has taken steps to regulate Chinese Proprietary Products (CPM). All CPM are regulated under the Medicines Act and its subsidiary legislations. Under the Medicines Act, all local manufacturing facilities engage in the manufacture or assembly of CPM must be licensed with Health Sciences Authority.

Applicants for a manufacturer's licence should submit an online application form via PRISM. Manufacturers and assemblers are required to provide information on each CPM dealt by them and will be allowed to deal in approved CPM products only. The GMP Audit and Licensing Unit of Audit & Licensing Division (ALD) in Health Sciences Authority is responsible for the audit and licensing of CPM manufacturers and assemblers in accordance with current international Good Manufacturing Practice (GMP) standard. The manufacturing facilities will be assessed and audited for compliance with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products prior to the issuance of a manufacturer's licence. The holder of a manufacturer's licence shall comply with all the standard provisions and licensing conditions for a manufacturer's licence under the Medicines Act.

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products

For more information on the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products, please click here.

The PIC/S Guide to GMP for Medicinal Products Part I can be downloaded from here.

The PIC/S Guide to GMP for Medicinal Products Annexes can be downloaded from here.