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)
Flag Coat of arms
Motto:  “Majulah Singapura” (Malay) “Onward, Singapore”

Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience

by

Dr Daniel Tan
Director
Health Products Regulation Group
Health Sciences Authority

read all this at

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/WH-1_2Dec.pdf

overview

Mission
Background

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
system
In-house capabilities complemented by
external experts and advisory committee

Conclusion
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
timelines
For small markets like Singapore, this unique system of drug evaluation,
ensures that market entry of…

View original post 17 more words