Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience

New Drug Approvals

Republic of Singapore
Republik Singapura  (Malay)
新加坡共和国 (Chinese)
சிங்கப்பூர் குடியரசு (Tamil)
FlagCoat of arms
“Majulah Singapura” (Malay)
“Onward, Singapore”

Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience


Dr Daniel Tan
Health Products Regulation Group
Health Sciences Authority

read all this at



Regulatory Principles

Evaluation Routes
Data Requirements
Regulatory Process
Application Statistics

Pre-market Evaluation
Depth of evaluation varies following a risk-
& confidence-based approach
Three evaluation routes allowing flexibility
yet ensuring robustness in the registration
In-house capabilities complemented by
external experts and advisory committee

Resources are always limited in most regulatory agencies
Adopting a risk based approach to triage drug applications
Titrate the evaluation workload by levaraging on reference agencies
assessment reports
Managing Access to important medicines without prolonging
For small markets like Singapore, this unique system of drug evaluation,
ensures that market entry of…

View original post 17 more words

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s