Establish a quality system that ensures your products are properly handled, stored and distributed to assure quality and integrity throughout the supply chain.
Good Manufacturing Practice (GMP) is a vital component of Quality Assurance to help ensure that CTGTP are consistently produced with the quality standards appropriate for their intended use.
All manufacturers (including those conducting secondary packaging) of CTGTP which is not minimally manipulated and intended for clinical use, are required to comply with the HSA Guidelines on Good Manufacturing Practice (GMP) for CTGTP 854 KB.
Good Distribution Practice (GDP) is a vital component of Quality Assurance. It requires the company to establish a quality system which ensures that products are stored and handled under appropriate conditions as required by the product registration or product specification.
Compliance to our Guidance Notes on Good Distribution Practice 263 KB is mandatory for all local importers and wholesalers of CTGTP which is not minimally manipulated and intended for clinical use in Singapore.
Regulatory overview
Class 1 CTGTP notification
Register a Class 2 CTGTP
Variation applications
Dealer's notice
Dealer's licensing and certification
Risk management plan requirements
Report adverse events
Report or recall defective products
Clinical trials
Product consultation
Advertisements and promotions
Certificate of a Pharmaceutical Product
Duties And Obligations
Guidance documents
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
CTGTP E-services