Functions
The Expert Advisory Group on Bioavailability and Bioequivalence ("BABE") Studies is set up under the Pharmacy and Poisons Board to :
| (a) |
provide the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances) Committee ("Registration Committee") with professional advice on the implementation plan of requiring BABE studies as a registration requirement for generic drugs by phases; |
| (b) |
provide professional support to the Registration Committee on issues relating to BABE studies;
|
| (c) |
provide expert opinion on the methodology and protocol of BABE studies proposed by applicants of pharmaceutical product registration; and |
| (d) |
provide expert opinion on the study data submitted by applicants of pharmaceutical product registration. |
Membership
| Chairman |
• Mr CHAN Ling-fung, Frank, JP |
| Members |
• Dr CHENG, Celine
• Prof CHEUNG Man-yung, Bernard
• Dr FAN Yuen-man, Cecilia
• Prof JOHNSTON, Atholl
• Prof LAM Ching-wan
• Prof LEE Wing-yan, Vivian
• Mr LING Ho-ming, Michael
• Prof LUK On-yan, Andrea
• Prof SMITH, David
• Prof WONG Chi-kei, Ian
• Mr WONG Yik-cheong, Anthony
• Ms YUEN, Karen
• Prof ZUO Zhong, Joan
|
| Secretary |
• Mr YEUNG Yee-fai, Raphael |
|