Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
November 26, 2012 [Liberty Times reporter Qiu Yijun reported]
Huang Linhuang, chairman of the Committee on Chinese Medicine and Pharmacy under the Department of Health, stated yesterday that over 400 types of scientific Chinese medicine produced by domestic GMP-certified pharmaceutical factories may be available for trial sales in China’s West Coast Economic Zone early next year. This would mark the first time China opens its market to imported Chinese medicine from Taiwan. However, Huang Linhuang also admitted that while Taiwan currently leans toward one-way exports to China, the possibility of two-way trade cannot be entirely ruled out—meaning Chinese-produced Chinese medicine might also be allowed for import into Taiwan.
Huang Linhuang, speaking at the "60th Anniversary Celebration of the Chinese Medicine Association of the Republic of China," noted that Chinese medicine reimbursements account for about NT$20 billion annually, roughly 4% of the total health insurance budget. The reimbursed medications include traditional preparations and concentrated formulations that meet GMP standards. The Department of Health is currently negotiating with Chinese authorities to allow these concentrated formulations, commonly known as "scientific Chinese medicine," to enter the Chinese market as "pharmaceutical products." If successful, trial sales in the West Coast Economic Zone could begin next year.
Shih Chun-chuan, chairman of the Taiwan Association for Quality in Chinese Medicine, expressed concerns that China’s GMP system is not yet fully established, with very few Chinese medicine GMP-certified factories and inadequate quality control enforcement. "Their pharmaceutical quality lags behind Taiwan’s by at least several decades!" Additionally, China’s pharmaceutical licensing is relatively lenient, with regulations even permitting the mixing of Western drugs into Chinese medicine, resulting in complex formulations that raise safety concerns.
Wang Hsueh-ling, general manager of Sun Ten Pharmaceutical, pointed out that 90% of the raw materials for Taiwan’s Chinese medicine come from China. However, Taiwan has been unable to sell scientific Chinese medicine in China, as Chinese authorities classify it as a "new drug" and require costly clinical trials, often costing millions of RMB, making market entry difficult for pharmaceutical companies. If trial sales are allowed in the future, manufacturers would welcome the development.
Chen Chao-tsung, chairman of the Taipei Chinese Medicine Doctors Association, also noted that the quality of Chinese-produced Chinese medicine is inconsistent. If two-way trade is opened, it could pose risks to public health. Shih Chun-chuan advised the Department of Health to prioritize strict border inspections for imported Chinese herbal materials and not to easily abandon Taiwan’s long-standing quality standards for Chinese medicine.
Source: http:/ / tw. news. yahoo. com/ % E7……2% BE% E9% 8A% B7- 203019112. html
Science-Based TCM to Launch Next Year, Equal Access Faces Dumping Risks
Huang Linhuang, chairman of the Committee on Chinese Medicine and Pharmacy under the Department of Health, stated yesterday that over 400 types of scientific Chinese medicine produced by domestic GMP-certified pharmaceutical factories may be available for trial sales in China’s West Coast Economic Zone early next year. This would mark the first time China opens its market to imported Chinese medicine from Taiwan. However, Huang Linhuang also admitted that while Taiwan currently leans toward one-way exports to China, the possibility of two-way trade cannot be entirely ruled out—meaning Chinese-produced Chinese medicine might also be allowed for import into Taiwan.
Huang Linhuang, speaking at the "60th Anniversary Celebration of the Chinese Medicine Association of the Republic of China," noted that Chinese medicine reimbursements account for about NT$20 billion annually, roughly 4% of the total health insurance budget. The reimbursed medications include traditional preparations and concentrated formulations that meet GMP standards. The Department of Health is currently negotiating with Chinese authorities to allow these concentrated formulations, commonly known as "scientific Chinese medicine," to enter the Chinese market as "pharmaceutical products." If successful, trial sales in the West Coast Economic Zone could begin next year.
Shih Chun-chuan, chairman of the Taiwan Association for Quality in Chinese Medicine, expressed concerns that China’s GMP system is not yet fully established, with very few Chinese medicine GMP-certified factories and inadequate quality control enforcement. "Their pharmaceutical quality lags behind Taiwan’s by at least several decades!" Additionally, China’s pharmaceutical licensing is relatively lenient, with regulations even permitting the mixing of Western drugs into Chinese medicine, resulting in complex formulations that raise safety concerns.
Wang Hsueh-ling, general manager of Sun Ten Pharmaceutical, pointed out that 90% of the raw materials for Taiwan’s Chinese medicine come from China. However, Taiwan has been unable to sell scientific Chinese medicine in China, as Chinese authorities classify it as a "new drug" and require costly clinical trials, often costing millions of RMB, making market entry difficult for pharmaceutical companies. If trial sales are allowed in the future, manufacturers would welcome the development.
Chen Chao-tsung, chairman of the Taipei Chinese Medicine Doctors Association, also noted that the quality of Chinese-produced Chinese medicine is inconsistent. If two-way trade is opened, it could pose risks to public health. Shih Chun-chuan advised the Department of Health to prioritize strict border inspections for imported Chinese herbal materials and not to easily abandon Taiwan’s long-standing quality standards for Chinese medicine.
Source: http:/ / tw. news. yahoo. com/ % E7……2% BE% E9% 8A% B7- 203019112. html