The First USP-Verified Chinese Medicine Ingredient in the World
As the rising status, Chinese medicine has been widely applied to the field of health care, people become more concern of their quality and safety. Recently a Chinese medicinal ingredient in Hong Kong ---- using a new technology to extract pure freeze-dried Coriolus versicolor, this extract successfully passed the international authority and certification process of the United States Pharmacopoeia. It become the first Chinese medicinal ingredient obtains the certification of plant extracts and food supplements in Hong Kong. A press conference was held and many local and overseas industry leaders were invited. Everyone witnessed this standard presentation ceremony of the United States Pharmacopoeia. This made an opening of Chinese medicine to internationalization.
(Above) Purapharm International (H.K.) Ltd.’s first Chinese medicinal extracts manufacturer was certified by "United States Pharmacopoeia", this was a first step towards the internationalization of Chinese medicine.
United States Pharmacopoeia Commission is a standard for a statutory public authority in U.S., such as prescription, non-prescription drugs and other health care products standard setting, which is gained by U.S. Food and Drug Administration (FDA). More than 130 countries have adopted the United States Pharmacopoeia as their national pharmacopoeia around the world. Products and ingredients certified by USP will be an important quality of identification to consumers.
Dr. B.W. Wong, the founding president of the International Association of Chinese Modernization Medicine, led the co-operation between Hong Kong and the United States Pharmacopoeia. He said at the press conference," Product quality in traditional Chinese medicine depends on safety, quality and efficacy. But there is no consensus of the international safety and quality standards for Chinese medicine, so that our Association signed an agreement with the United States Pharmacopeia three years ago, introduce a certification program of food supplements in China region help the local Chinese medicinal company's product to improve the safety, quality and strive for the United States Pharmacopoeia certification. This wants to make Chinese medicinal products internationalize.
(Above) Dr. B.W. Wong said that it can help to enhance brand reputation if Chinese medicine obtained the certification of USP.
Two years hard work for USP Certification
In 2007 United States Pharmacopoeia set up headquarters in China, presently China got 10 drugs and Hong Kong got 1 successful authentication, the other does not belong to traditional Chinese medicine. Getting the mark of United States Pharmacopeia Dietary Supplement Ingredients(DSIVP), must pass a series strict monitoring. Dr. Wu, General Manager in China region of United States Pharmacopoeia Commission, pointed out that certification program included food supplements, ingredients and products, pharmaceutical ingredients and so on. Producer of participation in the certification program must pass the on-site production GMP audits, comprehensive documentation review, sample purity and effectiveness of independent testing, in other words products from raw materials, production, packaging and storage must be meticulous, during which have to go through an independent laboratory by the purity and heavy metal testing, security testing to ensure that each batch of products that meet certification standards. "
(Above) Dr. Wu said that it still need regular monitoring after the product certified by the United States Pharmacopoeia.
Everything is difficult at starting, Hong Kong Chinese medicine and food need to go through a series of hurdles to get the mark of DSIVP. Mr. Abraham Chan, chairman of Purapharm International (H.K.) Ltd, the first one gave out the resources to promote the modernization of Chinese medicine development to take part in the United States Pharmacopoeia certification program. He said, " Company produces more than 700 kinds of products, we choose one of the most high-quality products----Oncozac Medicinal versicolor to participate in the scheme. It made a long time to communicate with the United States Pharmacopoeia of the certification process. On one hand, we need to find experts to conduct a detailed analysis of the product, on the other hand, we need to translated the information into English, and then submitted to the relevant departments. After two years we successfully got the approval by the U.S. Pharmacopoeia and got the award of DSIVP certification. Although many problems were encountered in the process, but I wish this will be able to enhance the acceptability of traditional Chinese medicine, to benefit both manufacturers and consumers.
(Above) Mr. Abraham Chan notice that more products will participate in the U.S. Pharmacopoeia certification program
