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China Drug Agency Details Process Changes at ChinaTrials 2009

Tuesday, November 10, 2009

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. 

“To solve issues surrounding timelines, we need to put ourselves under the magnifying glass,” Feng said. The GRP problem became apparent after China’s regulatory agency, State Food and Drug Administration (SFDA), participated in a survey conducted by UK-based International Institute for Regulatory Science (IIRS) rating 13 emerging markets’ clinical research regulatory systems. China’s participation in the survey reflects the agency’s strong interest in improving the current review and approval system and its desire to know how it stacks up against other countries’ regulatory systems. In addition to answering IIRS’ questionnaire, SFDA has actively studied other Asian countries’ systems as well as those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. 

After studying FDA’s GRP, a further analysis of Chinese market conditions was made so that the country’s GRP would better fit its market and Chinese characteristics. 

“For GRP, our team made intensive study and learned from overseas,” Feng said. “For our GRP, we adopted three key values: the first is ‘science,’ the second is ‘fairness and justice,’ and the third is ‘transparency.’ These would be the values that would affect the reviewing results of SFDA.” 

GRP implementation has been about 10 years in coming. China’s first introduction to GRP was in 2000 and its first GRP workshop was in 2004. “After 10 years of effort, we have designed science-based review criteria and standards,” Feng said. “We have to align every stakeholder’s interest together.” A GRP task force has also been set up. 

While Feng emphasized throughout his presentation the need for a science-based decision-making system, he cited the inexperience of CDE review staff as an issue. “Our team is a new team. The average age of team members is 39 years old. In terms of R&D management exposure, that’s pretty young,” he said. As he did last year at ChinaTrials 2008, Feng noted that CDE is understaffed. Headcount was at 118 last year, and it was implied that that would not be added to much this year. He also expressed the need for CDE staff internal training to be enhanced. 

In the past, Feng said that his job was “easy.” The focus was on over-the counter products and CDE held a couple of meetings per year, according to him. “Now we need a robust process to drive review,” he said. He referred a few times to the “steep learning curve” involved in transitioning from mainly generics review to review of new drugs and that it takes time. 

One of the most striking aspects of Feng’s presentation was the repeatedly expressed desire for openness. Feng called transparency a “critical element” of GRP. “Regulators need to communicate more with industry in terms of the reviewing system and process of drugs and provide more information.” Though SFDA has opened up communication channels for new drug registration, lack of consistency in reviewing decisions is a common complaint from sponsor companies about the agency. 

Perhaps, the solution to that problem is increased review specialization. Feng stated that a “different new process for different drugs and events” was needed as well as a “special review for new drugs.” 

Feng concluded, “With increasing momentum of simultaneous [drug development programs] we need to be faster in adopting best practice.”

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