In late January, Singapore’s Health Sciences Authority (HSA) published an updated guidance on defect reporting and recall procedures for therapeutic products in Singapore. The new guideline applies to therapeutic products, including biologics, as well as cell, tissue, and gene therapy products. It outlines what needs to be done when product defects are identified.
Companies will need to notify the HSA if they identify any defects that may affect the safety, quality, or efficacy of a product. Defects are generally classified based on their level of risk. More serious issues require expedited reporting and immediate action. The guidance explains what constitutes a reportable defect, which helps companies distinguish between issues that require formal notification and those that may be managed through other regulatory pathways.
In addition, the guideline specifies HSA’s expectations for investigation and risk assessment following the identification of a defect. Companies should conduct timely evaluations, determine the scope of affected batches, assess potential health risks, and propose appropriate corrective actions. Corrective measures may include recalls at the wholesale or consumer level. The HSA emphasizes that routine regulatory submissions, such as variation applications, do not replace the requirement to file a formal defect report.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.