Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
Lin Yixin: Director of the Committee on Chinese Medicine and Pharmacy, Department of Health, with a Ph.D. in Science from Tsinghua University. Former member of the Drug Review Committee of the Department of Health, review committee member of the Committee on Chinese Medicine and Pharmacy, standing director of the National Union of Chinese Medicine Practitioners, standing director of the Integrated Chinese and Western Medicine Association, chief of the Internal Medicine Department at the Chinese Medicine Division of Chang Gung Memorial Hospital, and chairman of the Chinese Medicine Education Committee.
By Huang Huiru
November 2006, Common Health Magazine, Issue 96
Q: After the Committee on Chinese Medicine and Pharmacy banned Chinese medicines containing aristolochic acid, the number of new kidney disease cases dropped the following year, earning recognition from the nephrology community. However, there are still many Chinese medicines containing aristolochic acid, such as those in the Asarum family. How will these be handled?
A: At that time, our swift, decisive, and proactive actions were praised by the media and the public. Later, the Department of Health and the Executive Yuan considered it one of the classic examples of crisis management and public policy implementation.
This year, we are implementing the "Chinese Herbal Medicine Safety Information Center Project" to study which herbs are harmful to the liver and kidneys. Once we have a clear understanding, we will establish a database that both industry professionals and the public can access. Additionally, we hope to establish a diagnostic system for Chinese medicine practitioners, incorporating not only traditional wisdom but also new diagnostic indicators.
However, medicine is inherently toxic. Just because something has nephrotoxicity doesn't mean it should be banned. Many Western medicines also have nephrotoxic or hepatotoxic effects, but they can still be used under a doctor's prescription. Chinese medicine should be held to the same standard.
Aristolochic acid was banned not because of its nephrotoxicity but because of its carcinogenicity. If we find that a Chinese medicine has nephrotoxicity, we will take three measures. First, issue a warning by adding cautionary labels to the product. Second, intensify research into the risks and benefits. Only then will we consider whether to ban it. Since the medicinal material is originally legal, any regulation or revocation must be evidence-based. We are currently using research projects to gather this evidence.
Q: Some believe that Taiwan's heavy metal limits for Chinese medicine are too lenient, making them the most backward standards in the world. What is your response?
A: We would not use the term "backward." In fact, our regulations are neither more backward nor more lenient. Other countries treat Chinese medicine as food, so their regulations are stricter. We treat it as medicine, with doctors overseeing its use, and it is not intended for long-term use.
Moreover, regulation is also related to industrial capacity. You could set the strictest standards in the world, but then there would be nothing left to use.
Q: The World Health Organization (WHO) sets heavy metal limits for Chinese medicine at 1ppm for lead and 0.03ppm for cadmium. Our limits are 30ppm for lead and 2ppm for cadmium.
A: The WHO regulates all countries. Since most countries do not value Chinese medicine, they manage it using food standards. We manage it using pharmaceutical standards.
In the future, if more evidence emerges linking heavy metals in Chinese medicine to kidney disease, as with aristolochic acid, we will ban it.
To improve the safety of Chinese medicine, we have a five-year budget starting in 2004, which will run until 2009.
First, in March 2005, we began the full implementation of the Good Manufacturing Practice (GMP) system for Chinese medicine.
Previously, we had 200 traditional Chinese medicine manufacturers, 128 of which were not GMP-certified. I visited each manufacturer to understand their problems and needs, then guided 28 of them to upgrade to GMP standards and closed 100. This not only aligns with international standards but also meets consumer demands, ensuring a uniform quality control system.
We have also announced the "Chinese Herbal Pharmacopoeia," giving Chinese medicinal materials legal status and establishing quality control standards and specifications.
This year, for the first time, we conducted hospital evaluations to improve the quality of human resources, gaining insights into the teaching, medical, academic achievements, and public satisfaction of Chinese medicine hospitals.Q: Perhaps the government can demand pharmaceutical quality from GMP-certified factories, but what percentage of the total traditional Chinese medicine (TCM) market is produced by these GMP factories? Could it be that most people still buy TCM from traditional medicine shops, which the government cannot regulate?
A: The TCM market from GMP factories is approximately 8.1 to 11 billion, but there is also a 40 billion market for medicinal diets. This segment is distributed through imports, wholesalers, distributors, and finally sold in traditional medicine shops.
Our policy is straightforward: one aspect is packaging labeling, and the other is source management.
We aim to have packaging labels on the 300 most commonly used TCMs by the public before 2008. The significance of packaging labeling is threefold: 1. It establishes a responsibility system, with the manufacturer, importer, and seller clearly labeled on the packaging, clarifying responsibility. 2. It specifies the shelf life. 3. It clearly states the ingredients.
After completing the packaging labeling, we will promote "source management." This involves legal announcements to set control standards, including limits on heavy metal residues, pesticide residues, pollutants, and microorganisms, thereby enforcing product responsibility. This will prevent the previous scenario where shops would shift responsibility to distributors, who in turn would shift it to wholesalers.
Previously, we did not recognize herbal teas and herbal shops as "TCM," yet the public used them on their own. We will use the "National Center for Adverse Reaction Reporting of Chinese Herbal Medicines" to alert the public about the misuse of certain herbs.
Q: Since 90% of TCM is imported from mainland China, how can source management be effectively implemented?
A: After joining the WTO, setting up checkpoints at customs for inspection could be seen as a trade barrier, presenting a dilemma.
We are now adopting the same approach as many countries, which is post-landing tracking. The source is the responsibility of the manufacturers, and after landing, management is through packaging labeling. If there are any issues, the products are removed from shelves, recalled, and destroyed.
Q: How is tracking done after landing?
A: We have launched the "Modernization Plan for TCM Shops," aiming for half of the TCM shops to operate in a modernized manner by 2009, similar to 7-Eleven. We have also designed a logo, and in the future, the public will recognize and choose modernized TCM shops by this logo.
Source: http://www. commonhealth. com. tw/ article/ index. jsp? id=823
Lin Yixin (Chairman of TCM Committee, Department of Health): Establish Safe TCM Environment within 3 Years
By Huang Huiru
November 2006, Common Health Magazine, Issue 96
Q: After the Committee on Chinese Medicine and Pharmacy banned Chinese medicines containing aristolochic acid, the number of new kidney disease cases dropped the following year, earning recognition from the nephrology community. However, there are still many Chinese medicines containing aristolochic acid, such as those in the Asarum family. How will these be handled?
A: At that time, our swift, decisive, and proactive actions were praised by the media and the public. Later, the Department of Health and the Executive Yuan considered it one of the classic examples of crisis management and public policy implementation.
This year, we are implementing the "Chinese Herbal Medicine Safety Information Center Project" to study which herbs are harmful to the liver and kidneys. Once we have a clear understanding, we will establish a database that both industry professionals and the public can access. Additionally, we hope to establish a diagnostic system for Chinese medicine practitioners, incorporating not only traditional wisdom but also new diagnostic indicators.
However, medicine is inherently toxic. Just because something has nephrotoxicity doesn't mean it should be banned. Many Western medicines also have nephrotoxic or hepatotoxic effects, but they can still be used under a doctor's prescription. Chinese medicine should be held to the same standard.
Aristolochic acid was banned not because of its nephrotoxicity but because of its carcinogenicity. If we find that a Chinese medicine has nephrotoxicity, we will take three measures. First, issue a warning by adding cautionary labels to the product. Second, intensify research into the risks and benefits. Only then will we consider whether to ban it. Since the medicinal material is originally legal, any regulation or revocation must be evidence-based. We are currently using research projects to gather this evidence.
Q: Some believe that Taiwan's heavy metal limits for Chinese medicine are too lenient, making them the most backward standards in the world. What is your response?
A: We would not use the term "backward." In fact, our regulations are neither more backward nor more lenient. Other countries treat Chinese medicine as food, so their regulations are stricter. We treat it as medicine, with doctors overseeing its use, and it is not intended for long-term use.
Moreover, regulation is also related to industrial capacity. You could set the strictest standards in the world, but then there would be nothing left to use.
Q: The World Health Organization (WHO) sets heavy metal limits for Chinese medicine at 1ppm for lead and 0.03ppm for cadmium. Our limits are 30ppm for lead and 2ppm for cadmium.
A: The WHO regulates all countries. Since most countries do not value Chinese medicine, they manage it using food standards. We manage it using pharmaceutical standards.
In the future, if more evidence emerges linking heavy metals in Chinese medicine to kidney disease, as with aristolochic acid, we will ban it.
To improve the safety of Chinese medicine, we have a five-year budget starting in 2004, which will run until 2009.
First, in March 2005, we began the full implementation of the Good Manufacturing Practice (GMP) system for Chinese medicine.
Previously, we had 200 traditional Chinese medicine manufacturers, 128 of which were not GMP-certified. I visited each manufacturer to understand their problems and needs, then guided 28 of them to upgrade to GMP standards and closed 100. This not only aligns with international standards but also meets consumer demands, ensuring a uniform quality control system.
We have also announced the "Chinese Herbal Pharmacopoeia," giving Chinese medicinal materials legal status and establishing quality control standards and specifications.
This year, for the first time, we conducted hospital evaluations to improve the quality of human resources, gaining insights into the teaching, medical, academic achievements, and public satisfaction of Chinese medicine hospitals.Q: Perhaps the government can demand pharmaceutical quality from GMP-certified factories, but what percentage of the total traditional Chinese medicine (TCM) market is produced by these GMP factories? Could it be that most people still buy TCM from traditional medicine shops, which the government cannot regulate?
A: The TCM market from GMP factories is approximately 8.1 to 11 billion, but there is also a 40 billion market for medicinal diets. This segment is distributed through imports, wholesalers, distributors, and finally sold in traditional medicine shops.
Our policy is straightforward: one aspect is packaging labeling, and the other is source management.
We aim to have packaging labels on the 300 most commonly used TCMs by the public before 2008. The significance of packaging labeling is threefold: 1. It establishes a responsibility system, with the manufacturer, importer, and seller clearly labeled on the packaging, clarifying responsibility. 2. It specifies the shelf life. 3. It clearly states the ingredients.
After completing the packaging labeling, we will promote "source management." This involves legal announcements to set control standards, including limits on heavy metal residues, pesticide residues, pollutants, and microorganisms, thereby enforcing product responsibility. This will prevent the previous scenario where shops would shift responsibility to distributors, who in turn would shift it to wholesalers.
Previously, we did not recognize herbal teas and herbal shops as "TCM," yet the public used them on their own. We will use the "National Center for Adverse Reaction Reporting of Chinese Herbal Medicines" to alert the public about the misuse of certain herbs.
Q: Since 90% of TCM is imported from mainland China, how can source management be effectively implemented?
A: After joining the WTO, setting up checkpoints at customs for inspection could be seen as a trade barrier, presenting a dilemma.
We are now adopting the same approach as many countries, which is post-landing tracking. The source is the responsibility of the manufacturers, and after landing, management is through packaging labeling. If there are any issues, the products are removed from shelves, recalled, and destroyed.
Q: How is tracking done after landing?
A: We have launched the "Modernization Plan for TCM Shops," aiming for half of the TCM shops to operate in a modernized manner by 2009, similar to 7-Eleven. We have also designed a logo, and in the future, the public will recognize and choose modernized TCM shops by this logo.
Source: http://www. commonhealth. com. tw/ article/ index. jsp? id=823