Dealer's licensing and certification

Good Distribution practice (GDP) guides

• Guidance Notes on Good Distribution Practice 263 KB  

Good Manufacturing Practice (GMP) guides

HSA guides

• HSA Guidelines on Good Manufacturing Practice for CTGTP854 KB

PIC/S guides

• Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (PIC/S PE 008-4)

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for CTGTP

• Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP

• Singapore-Specific Annex (SSA)
• Safety Notification Form

Reporting product defects and recall CTGTP

• Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products449 KB
• Video guide on product defect reporting and recall in Singapore. This video brings you through the considerations on whether a product defect needs to be reported to us, and the steps to report the defect or recall the product.

• Online Product Defect Reporting Form
• Online Product Recall Completion Form

Clinical trials

Refer to our clinical trials section for the guidance documents.