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SFDA, Big Pharma Share Concerns at Shanghai Conference

Monday, November 24, 2008

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 (CFDA) gave a broad overview of the evolution of global clinical trials in China and pinpointed future trends and goals in the country.

Feng said the key to the future of the clinical research market in China is clear: “The regulatory agency and industry need to work together to create better synergy.” Big Pharma, whose key players in the Asia-Pacific region attended, agreed.

The majority of multinational clinical trials in China are in phases II and III, according to Feng, “but for phase I, China is still lagging behind its Asian counterparts.” Attendees’ later questions reflected the fact that, like India, China will not allow first-in-man studies unless the molecule was developed in-country.

SFDA is clearly looking over its shoulder at South Korea, acknowledging the country’s success in attracting multinational clinical trials. Both countries’ clinical research markets began in earnest in 2002 when each had new global clinical trial initiations in the mid-teens, but in the next four years, South Korea’s number of new global clinical trial initiations were nearly double those of China, at 160. “The sector has been growing very fast in South Korea,” Feng said, adding that Seoul is the most active city in Asia for local and multinational clinical trials. Beijing is a distant number nine.

According to Feng, China’s clinical research market has not grown faster is that the Center for Drug Evaluation (CDE) is understaffed. “Understaffing at CDE causes a potential risk for drug safety in China,” he said.

CDE is allowed only a certain number of employees (about 115 right now), Feng said, and the number of staff is low relative to the number of biopharmaceutical companies located in China. As more people can afford medicine in China, he said, it makes sense to expand staffing at CDE.

Addressing one of the most common complaints that sponsors lodge against SFDA—that approvals take too long—Feng said the main reasons for these delays are unclear protocols and dossiers that don’t meet requirements. He described the approval process as a shared responsibility.

“SFDA is taking too much accountability. The agency, subjects, CROs, sponsors, ethics committees and principal investigators are all important for the synergy. We need the right mix of responsibility to facilitate R&D,” Feng said.

For its part, the agency just posted the opinion draft of the special evaluation procedures on its web site on October 21.

“This draft is a major milestone in multinational clinical trials,” Feng said.

At the end of his presentation, Feng provided a rare question-and-answer opportunity for multinational pharma and CROs.

Representatives of pharma and CROs alike clamored for the mic to ask their questions. Both Ling Su, Ph.D., vice president of Clinical Development, Asia-Pacific, Wyeth, and Frank Jiang, M.D., Ph.D., vice president, Global R&D/Head China R&D, Sanofi-Aventis, asked what pharma could do to help SFDA work more efficiently.

“I would challenge ourselves as a community to define breakthrough areas to work on that have manageable scope and impact,” Su said.

“What can pharma do to help SFDA and CDE to review things faster?” Jiang later asked.

Su pointed to poor communication as a cause for delay. “For simultaneous global development to be successful, we need more communicators, not messengers,” he said. “We want to submit to China at the same time as the U.S. and the EU, but we can’t.” Su is also chair of DIA’s Provisional Advisory Council of China, which will support DIA’s new Beijing office.

Feng acknowledged that collaboration is needed to figure out what needs to be done but re-emphasized CDE’s lack of staffing and budgetary concerns as a major challenge. Earlier in his talk, he had alluded to the agency’s plans to implement videoconferencing to make communications easier.

In answer to others’ questions, Feng acknowledged that SFDA needed to “enhance statistics capability.”

Others asked if SFDA would allow more phase I clinical trials in China. Feng’s answer was blunt, “SFDA will do things in line with the law. My answer is ‘no.’ You have to complete phase I outside of China. The existing laws and regulations reflect current situations. The laws and regulations are behind, a little out of date. To improve efficiency, we must improve the legal framework. We need to do a good job in risk management. Too much approval may not be a good thing in China.”

Feng ended his talk, which ran for twice as long as the time allotted due to the question-and-answer period, by saying that he wanted the SFDA to be an “open, transparent, science-based agency.”

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