DIA Biosimilars 2013

CDE

China Drug Agency Details Process Changes at ChinaTrials 2009

Tuesday, November 10, 2009 06:26 AM

At the ChinaTrials 2009 conference in Beijing Monday, Dr. Yi Feng, director of Review Management, Center for Drug Evaluation (CDE) in China, laid out plans to implement a new GRP process. GRP is an acronym representing three “R” practices: Good Review Practice, Good Regulatory Practice and Good Registration Practice. It is expected that implementing GRP will greatly contribute to shortening drug review timelines in China. 

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Cenduit: Now with Patient Reminders

SFDA, Big Pharma Share Concerns at Shanghai Conference

Monday, November 24, 2008 09:00 AM

In his regulatory keynote address at the China Trials 2008 conference in Shanghai, Dr. Yi Feng, director, Office of Review Management, Center for Drug Evaluation (CDE), State Food and Drug Administration (SFDA) gave a broad overview of the evolution of global clinical trials in China and pinpointed future trends and goals in the country.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

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New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
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Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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