How to improve the overseas standards of plant extracts in China?

Under the circumstances that foreign governments strengthen the supervision of Chinese products and improve the testing standards, domestic enterprises must improve the standards through scientific and technological innovation When the export of traditional Chinese medicine products generally declined, the export growth rate of plant extracts was about 20% How to maintain the growth rate and expand the market share with the increase of foreign access threshold has become a hot topic in the 4th "China plant extract development and innovation" forum recently held in Shanghai This forum, which was held at the same time with "2009 world pharmaceutical raw materials China Exhibition" and sponsored by China Chamber of Commerce for import and export of pharmaceutical and health care products (hereinafter referred to as the medical insurance chamber of Commerce), attracted many domestic plant extract companies to attend Since the implementation of the U.S FDA dietary supplement CGMP regulations in August 2008, the transition period for enterprises with 20-500 employees ended on June 25 this year, and the above CGMP regulations also regulate foreign finished product suppliers For this reason, the forum specially invited experts from the natural drug association of the United States to interpret relevant issues The threshold has been raised "According to the cGMP Implementation Regulations for American health care industry released by the United States, cGMP transformation will be enforced for all companies producing and selling vitamins, mineral preparations, plant preparations and various dietary supplements by June 2010, and new standards will be formulated for manufacturers, suppliers and packaging companies of dietary supplements and other products The requirements of these new standards require American companies to ask their suppliers for more specific information about raw materials, which will undoubtedly increase the difficulty for exporters to export to the United States " Zhang Chengwen, acting president of plant extract branch of medical insurance chamber of Commerce and general manager of Xi'an Haotian Bioengineering Technology Co., Ltd Jeff Clausen, chief representative of CNDA China office, said that the FDA's cGMP, a dietary supplement, has been implemented since August 2008 Considering the enterprise's tolerance, the FDA has given a three-year transition period According to this regulation, if there are more than 500 employees in the enterprise, the transition period has expired on June 26, 2008; if there are less than 20 employees, the transition period will expire on June 25, 2010; if there are 20-500 employees, the transition period will expire on June 25 of this year It is understood that companies with more than 500 people in the United States are more powerful companies, so they are not affected much Enterprises with the size of 20-500 people account for 1 / 3 of the total number of healthy food manufacturers in the United States It is expected that the vast majority of these enterprises will face the test of cGMP transformation As the United States is the largest market for Chinese plant extracts, the plant extracts exported from China to the United States are basically used in the field of health products and food additives The above cGMP transformation in the United States is bound to affect Chinese suppliers Jeff Clausen pointed out that at present, China's raw material suppliers must note that American buyers will have to require and verify ingredient suppliers in accordance with CGMP regulations Therefore, American buyers will tend to find Chinese companies that meet the cGMP certification of the United States to cooperate In addition, FDA has set up an office in China to inspect suppliers, so Chinese suppliers must actively respond to the above policy changes China's response to statistics from the customs shows that under the influence of the global financial crisis, in January April 2009, when the export of other traditional Chinese medicine commodities declined, the export of plant extracts was unique, with a total export volume of 200 million US dollars, up 20% year on year Zhang Chengwen pointed out that the above data showed that China's plant extraction industry is stepping out of the shadow of the financial crisis The downturn in the global economy has brought some special situations to American dietary supplement suppliers Although most companies face some difficulties in operation, mainly due to the tighter capital and credit, and the slow development of new products, sales have increased At the same time, participants also noted that although the use characteristics of plant extract products have determined that their international demand is rigid, to share the growth of the mainstream market, especially the U.S market, the precondition must be to connect with international standards and actively improve product quality standards "It's an inevitable trend to raise the industry threshold." Li Chunhua, general manager of Beijing Green Gold Biotechnology Co., Ltd., pointed out that under the circumstances that foreign governments strengthen the supervision of Chinese products and improve the testing standards, domestic enterprises must improve the standards through scientific and technological innovation, "the formulation of quality standards for Chinese plant extracts should be in line with international standards as soon as possible In addition, in addition to enterprises should strengthen self-discipline, industry associations should also guide enterprises to carry out system certification Government departments should consider allowing the introduction of independent third-party testing and certification institutions to promote supervision " According to the research report from the Department of traditional Chinese medicine of the medical insurance chamber of Commerce, more and more countries in the world tend to use fingerprint technology for quality control of plant drugs, especially plant extracts At present, China's plant extract manufacturers also have the basic conditions for fingerprint testing, so it is time to vigorously promote fingerprint technology to control product quality The reporter learned from the plant extract branch of the chamber of Commerce of medical insurance that they are speeding up the formulation of foreign trade standards for plant extracts in response to the policy changes in the international market, and called on relevant national departments and enterprises to actively participate in the research of the standard system It is reported that in the green industry standards for foreign trade of medicinal plants and preparations led by the branch, the foreign trade standards for extracts of angelica, Hypericum perforatum, Trifolium pratense, Valeriana and Fructus aurantii have been released, and the foreign trade standards for ginseng, green tea and ginkgo have been formulated; in addition, acanthopanax senticosus, wolfberry, Polygonum cuspidatum, blueberry, Scutellaria, Siraitia grosvenorii, grape seed and pine Foreign trade standards for bark, Schisandra and echinacea are also being worked out.