Updates by HSA on Guidance documents with clarification on grouping

Health Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and GN-12-2-R2) and the class A exemption notification (GN-22-6.2).

For the Special Access route under GN 26 and GN 27 SAR for qualified practitioner and PHMC, the applicant company now requires quality management system in place eg. GDPMD certification.