PAPERCUTSImpact of Decision to Decline FDA Inspections of Factories Outside the US on Generic Medications in Singapore
- The Health Sciences Authority (HSA) evaluates all medicines, including generics, for safety, quality, and efficacy before and after registration, ensuring compliance with international Good Manufacturing Practice standards.
- HSA leverages its membership in the Pharmaceutical Inspection Co-operation Scheme to rely on inspections by other trusted regulatory bodies like the FDA, or conducts its own overseas inspections when needed.
- Post-market surveillance includes regular inspections of manufacturers and product quality sampling to ensure ongoing safety and quality of medications in Singapore.
- HSA exchanges information with international regulatory authorities to monitor medicine quality, including generics, and collaborates to address structural inspection challenges.