Regulatory Guidelines and Standards
All medicinal products are regulated under the Medicines Act and its subsidiary legislations. Under the Medicines Act, all local manufacturing facilities engaged in the manufacture or assembly of medicinal products must be licensed with Health Sciences Authority. Thus, no person shall manufacture or assemble any medicinal product except in accordance with a licence grant for the specific purposes (referred to in the Medicines Act as a Manufacturer's Licence).
Applicants for a manufacturer's licence should submit an online application form via PRISM.
The GMP Audit and Licensing Unit of Audit & Licensing Division (A&L) in Health Sciences Authority is responsible for the audit and licensing of medicinal product manufacturers and assemblers in accordance with current international Good Manufacturing Practice (GMP) standard. A manufacturer's licence would only be granted when the manufacturing facilities has been assessed, audited and found to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products. 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.
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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.
