China’s SFDA chief dismissed
The deputy chief of China’s State Food and Drug Administration (SFDA), Zhang Jingli, has been removed from his post and is being investigated by an anti-corruption body, the Party of China Central Commission for Discipline Inspection. Zhang, who had held the position since 2003, is under suspicion of “serious disciplinary violations” — a standard allusion by the Party Commission to bribery and corruption. There are no further details on the nature of Zhang’s offense.
This news comes three years after the former chief of this regulatory body, Zheng Xiaoyu, was executed for taking more than $900,000 in exchange for hundreds of drug product approvals. One of the approved drugs was an antibiotic that later resulted in several deaths.
Zheng Xiaoyu’s execution was considered severe even for China, a nation thought to administer more death sentences than any other. For a country with a history of poor product safety, this may be a step towards industry reform.
Chinese drug manufacturers have been blamed in recent years for several rounds of fatalities linked to poor-quality or counterfeit drug products. Most recently, in March of this year, there were allegations that faulty vaccines killed four children in northern China. Authorities denied a connection between the vaccine and the deaths. In 2008, baby formula tainted with melamine killed at least six infants and sickened thousands more.
Korea – U.S. Free Trade Agreement gains momentum
President Barack Obama has declared his intention to move forward with the Korea – U.S. Free Trade Agreement (KORUS). Written three years ago under President George Bush, it includes provisions on the pharmaceutical and medical devices markets. The Korean parliament has already passed the deal, while the Obama administration has yet to persuade Congress on the deal.
The agreement will expand markets for many sectors, including pharmaceutical products and medical devices. Most notably, KORUS details a commitment towards transparency in the pricing and reimbursement process, a provision for the creation of an independent review mechanism for pricing and reimbursement decisions in Korea and an agreement to establish a patent linkage system to ensure adequate enforcement of pharmaceutical intellectual property rights.
After meeting with South Korean President Lee Myung-Bak at the Toronto G20 summit, Obama announced that he wants issues blocking the agreement resolved by the Seoul G20 summit in November. Despite Obama’s enterprising attitude, he faces much opposition from his own Democratic party, who fear that this bilateral agreement will make U.S. industries more vulnerable to Korean competition.
The existing agreement has already been politically sensitive in Korea, with the Korean government expressing reluctance to renegotiate it a third time.
Diabetes to increase in Asia
Diabetes cases are dramatically on the rise in countries throughout Asia. Financially privileged city-dwellers tend to be the ones who have been identified as diabetics. Causes include insufficient exercise, high-fat diets that have increasingly incorporated fast food items, genetics and more.
A number of studies have attempted to record the current count of diabetics in countries including India, Vietnam, Thailand and China. The WHO has warned that India’s diabetics will rapidly grow from roughly 40 million (4 percent of the population) to 80 million (8 percent of the population) by 2030. Vietnam and Thailand are experiencing similar paths of diabetic development: 8.5 million in Vietnam and 6.5 million in Thailand (10 percent of their respective populations) are currently suffering from this condition.
China, in sheer numbers, has the largest population of diabetics of any one country. Already 92 million are inflicted with diabetes, and 180 million more are on the cusp of developing it. The increase of overweight children in Beijing is worrying many observers, as roughly 1 in 3 are now “clinically” overweight. China’s bout with diabetes is also alarming when considering the high rates of tuberculosis. Diabetes significantly exacerbates the symptoms of tuberculosis. These and other signs have prompted the Chinese government to increase the ways in which it tries to control the increase of diabetes. Recently, the Chinese Medical Assn. and the Chinese Medical Doctors Assn. issued the “China Medical Nutrition Therapy Guideline for Diabetes 2010” to raise awareness about diabetes.
Education on the causes of diabetes is vital to changing this trend. But as things stand, the number of medical drugs and devices is sure to dramatically increase to combat diabetes in Asia.
Japan and China work to promote global clinical trials
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s State Food and Drug Administration (SFDA) co-hosted a symposium at the end of May on Global Clinical Trials and Ethnic Factors. The conference facilitated discussion between the two countries concerning their participation in programs for international clinical development. The symposium addressed ethnic factors pertaining to multi-regional clinical trials and promoted the advancement of such trials in China and Japan.
Dr. Tatsuya Kondo, CEO of the PMDA, stressed the importance of collaboration between the two countries in his keynote speech. He recommended building upon each other’s "dynamism" and creating an East Asian medical device/drug community to relay its innovations to the rest of the world.
While efforts at regulatory harmonization have been a solid first step for Asian countries, Dr. Kondo advocated seeking further opportunities to share experiences and ideas amongst Asia’s medical communities, to network, collaborate, and develop ‘best-fit’ drugs for Asian populations.
He also presented several key issues for the realization of the PMDA’s goals, namely, the importance of timely discussion between pharmaceutical and medical device industries and regulatory agencies, the inclusion of Asia in multi-regional drug development, as well as further collaboration and harmonization amongst regulatory agencies. Dr. Kondo took it upon himself to ensure the creation of ‘high-level’ Japanese regulatory criteria which would be held to international standards.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at email@example.com.
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