Meet Yin Li: China’s New SFDA Chief Has A Public Health Background, And International Ties

Vice Minister of Health Yin Li assumes post as director of China’s State FDA, taking reigns from Shao Mingli, who led the agency since 2005.

SHANGHAI – During the last year rumors have swirled in industry about who will be the next director of China’s State FDA after the retirement of Shao Mingli, who has led the agency since 2005. The answer came Feb. 10 with the announcement that Vice Minister of Health Yin Li – China’s youngest ever vice minister – would take over the all important regulatory agency.

Born in Jinan, the capital of Shandong province in Eastern China, in 1962, Yin Li received a medical degree from Shandong Medical University in 1986 and a master’s in public health in 1988. He later went abroad and received a doctoral degree in health economics in Russia in 1993.

Upon returning to China, he worked at the research office under China’s State Council until 2003. During his work with the State Council – China’s cabinet – he also spent seven months during 2002-2003 in the U.S. at the Harvard School of Public Health as a visiting scholar.

At the State Council, “he developed a comprehensive understanding and grasp of China's complex socioeconomic, population, and health development issues as well as the policy-making process at the top level,” said Yuanli Liu, senior lecturer on international health at the Harvard School of Public Health and director of HSPH’s China Initiative.

“I have known Dr. Yin Li since the mid-1990s as a bright policy researcher/maker and as a good friend,” Liu told PharmAsia News.

“During his stay at Harvard School of Public Health as a visiting scholar, SARS broke out in China, and China's policy makers were initially puzzled about what proper course of actions to take,” Liu recalled. “Dr. Yin Li sent back a policy recommendation report, in which he outlined the major strategy for China to bring the crisis under control.”

“His report caught the attention of China's top leadership and he was summoned back to China immediately and was assigned a new job at the Ministry of Health,” Liu added.

China’s initial attempts to cover up the outbreak of severe acute respiratory syndrome, which emerged in southern China in late 2002, was a watershed event for global disease surveillance, and contrasted sharply with China’s preparedness and transparency during the A/H1N1 pandemic in 2009 (Also see "With A/H1N1, A Spectre Is Haunting China: The Spectre Of SARS" - Scrip, 16 Jun, 2009.).

In October 2003, Yin was promoted to director-general of MOH’s International Cooperation Department. In 2006, he also acted as director-general of the General Affairs Office, before becoming vice health minister in 2008.

“Dr. Yin Li is a very intelligent man with a rare combination of a keen sense of evidence-based policy making and courage to be innovative,” Liu said. “He is keenly aware of the science and technology gaps between China and industrialized countries. But he also knows well what is economically and politically feasible.”

“He is a man of efficiency and integrity. He appreciates well informed, evidence-based and candid dialogues. I am confident that under his leadership SFDA will be modernized to meet its increasingly important and challenging responsibilities,” Liu concluded.

SFDA’s transition to Yin’s leadership is mundane compared to the last transition at SFDA, when Shao Mingli rose from SFDA deputy director to take over for the disgraced Zheng Xiaoyu in 2005. Zheng was executed in 2007 following a high-speed trial on corruption charges for allegedly approving an array of pharmaceutical products without adequately testing their safety and efficacy (Also see "China Executes Former Food And Drug Head" - Scrip, 10 Jul, 2007.).

First Move is Safety

Just one week after Yin became director of SFDA, he gave his first public interview, talking with China’s government official press agency Xinhua about the 12th Five-Year Plan for Drug Safety.

The State Council released the plan Feb. 13, with a goal to raise quality standards for 6,500 drugs (See: Five-Year Plan For Drug Safety – Chinese language).

“All drugs and biologic products have to reach or be close to the global standards,” Yin said in his interview with Xinhua, adding that “more than 90% of medical devices have to adopt global standards.”

“First, the plan emphasizes ‘safety first’ … [and] requires implementing drug safety responsibilities, reducing the risk, and ensuring the safety of public medications, and insisting on ‘safety-first, scientific supervision’ as the basic principles of planning. The work focus is to improve drug standards and quality,” Yin noted (See: Interview With Xinhua – Chinese Language).

Before Yin joined SFDA, he also made comments last year related to food safety, noting that MOH is raising quality standards for food.

Given Yin’s international experience, more cooperation is expected between SFDA and fellow regulators. On Feb. 24, the new SFDA head traveled south to sign an agreement with the head of Macao’s Health Bureau to cooperate on drug regulatory supervision.

“As with his predecessor, Dr. Yin has a medical education background,” noted Henry Chen, a Shanghai-based partner at MWE China Law Offices, which is affiliated with the U.S. law firm McDermott Will & Emery.

“It is too early to comment whether or not he will bring make-a-difference reforms to the policies of SFDA,” Chen told PharmAsia News, but noted that Yin “did adopt some measures to reform the current health and medical system as the deputy health minister.”

Aside from food safety, the office of the deputy health minister has also been trying to implement a new system at hospitals to integrate a visiting card, payment card, personal health profile, and electronic medical records into one card.

SFDA Changes And Reform

Last year, SFDA reformed its drug review body, the Center for Drug Evaluation, to encourage drug innovation and facilitate globalization of its drug review process.

Under the old system, technical evaluations were delivered to one of four CDE review departments according to therapy area, and each department operated its own pharmacology and toxicology division. The reform breaks down those barriers to form a single department in charge of pharmacology and toxicology that will review all drugs (Also see "China's Center For Drug Evaluation Remakes Itself To Enter New Era Of Transparency, Speed Up Approvals" - Scrip, 11 Mar, 2011.).

In August, the head of CDE Li Guoqing was transferred to SFDA to head the department of drug safety and inspection.

Meanwhile, on Feb. 27, SFDA also opened a national communications center to receive public complaints about drugs and other products under its jurisdiction, including health foods, cosmetics and catering. The agency launched a new website www.12331.org.cn to receive complaints online and created a hotline for citizens to call in complaints, which will eventually be nationwide (Also see "China Opens Center For Public Complaints Of Drugs At All Levels" - Scrip, 28 Feb, 2012.).