Recently, Singapore’s HSA (the Therapeutics Products Branch, Health Products Regulation Group), updated many drug regulations. For new drug applications (NDAs), generic drug applications (GDAs), and major variation applications (MAV-1), companies can expect to receive their first evaluation feedback earlier than before. In addition, companies can use the webtool to help them better understand the drug approval timelines for their applications. Besides submitting their dossiers to HSA via Singapore’s online system, PRISM, drug applicants can also do so via a new cloud-based software system called EasiShare.
Also, HSA has also provided a list of post-approval changes that do not need to be reported any longer. One example of this change includes the fact that labelling changes with respect to machine QR codes for e-labeling are now not needed. Besides the US FDA, EMA, TGA, Health Canada, and MHRA as reference country regulators for Singapore, Swiss Medic is now also a reference country. As of October 1, 2024, manufacturers of chemical drug substances will need to meet GMP standards. Finally, Singapore will promulgate its eCTD specification package (version 1.0) in the third quarter of this year.
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.