ARQonDec 6, 20162 min readMore Green Channel Fast Track by China Food and Drug Administration (CFDA)In late October 2016, ARQon meeting with CFDA on the exchange sharing of fast track authorization route in Singapore and the Green...
ARQonOct 14, 20162 min readTherapeutic products: New Regulations & Clinical Trial of medical device: CRM replacing former tThe Health Sciences Authority of Singapore (HSA) introduced the Health Products Act (HPA) in 2007 in which their aim is to consolidate...
ARQonOct 14, 20161 min readRemoval of Singapore Quality Overall Summary from Drug Product Registration in SingaporeThe Singapore Quality Overall Summary (SQOS) was introduced in 2007 to provide information specific to product registration in Singapore....
ARQonJul 31, 20161 min readUpdates by HSA on Guidance documents with clarification on groupingHealth Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and...
ARQonJul 31, 20161 min readNew Singapore Standard will be replacing the current Technical Guidance by the end of the yearHealth Science Authority (HSA) will be rolling out a new Singapore Standard(SS) as early as November 2016. This new guidance will be...