CBA event

I attended a CBA event on April 19, 2009. It is a dinner workshop in Far East restaurant for SFDA delegation who come to Rockville for meeting with FDA. SFDA personnel are director level of medicinal product registration.  

CBA is not abbreviation for Chinese Basketball Association. J Any person from Mainland will have this wrong idea. Chinese Biopharmaceutical Association is a biotech organization here, in Maryland. It has 20 years history. Now, its member includes Professional from Industry, research institute and Government Agency.

Before dinner, Mr. Wei Zhang, Director General of the Department of Drug Registration gave a presentation on currant situation of Chinese pharmaceutical industry and New Regulatory System.

Bullet points:

l         Now, Chinese drug product sales are 17 billions, which is 2% of Global sales.

l         Chinese new drug development strategy changes from “Government Development” to “Corporation Development with support of Government”.

l         Coin several new Abbreviations: GRP (Good Regulatory Practice), GUP (Good utilization Practice and GVP (Good Vigilance Practice) … (I think it is 画虎不成反类猫, it is easy to cause confusion)

l         Intellectual protection: Innovation, Protection, Management, Application.

l         New registration system allows oversea marketed drug register in China through supplement (Technical transfer), not through generic drug pathway. (Speed up drug registration)

l         Establish Fast Track (特殊药品审批)for 4 categories of drug.  

l         Commodities and Cosmetics will be regulated by SFDA. Previously, They are regulated by Health Department.

 Besides SFDA personal, CBA also invite some Chinese FDAer. A FDAer sitting beside is a  Shanghainess. To my surprises, her cousin is Deputy Mayor of Shanghai……….