It is planned to stop the approval or full stop of the entrusted processing of traditional Chinese medicine extraction

Source: on November 26, 2013, just before the daily economic news, CFDA issued the draft for comments (hereinafter referred to as the draft for comments) on the notice on strengthening the supervision and management of Chinese herbal extracts According to the draft, from the date of issuance of the notice, all local drug administrations shall stop the examination and approval of the entrusted processing of traditional Chinese medicine, and the previously approved entrusted processing shall be strengthened in strict accordance with the requirements of the notice on strengthening the supervision and management of the pre-processing and extraction of traditional Chinese medicine (gjja [2002] No 84) issued by the former State Drug Administration At the same time, the draft also said that since January 1, 2016, all Chinese patent drug manufacturers that do not have the ability to extract traditional Chinese medicine will stop the production of corresponding varieties, and the approved entrusted processing will be abolished Some industry insiders said that the industry will meet the trend of merger, "for small enterprises, it is a good opportunity to stop production; for large enterprises, it is a good opportunity for merger and integration." Wang Shengyong, editor in chief of genuine herbal medicine website, told reporters that the draft was issued mainly to improve the quality of traditional Chinese medicine If the raw materials are not guaranteed, the quality of traditional Chinese medicine can not be guaranteed, especially for traditional Chinese medicine injection, impurities or toxins will bring direct life risk to patients Wang Shengyong once worked in the provincial drug inspection institute and was specially responsible for the resources and quality standards of traditional Chinese medicine He said that at present, the detection of traditional Chinese medicine is mainly to detect the content and ingredients Sometimes even if the indicators are reached, it may not be extracted from traditional Chinese medicine in fact The self built raw material extraction production line of the enterprise is obviously conducive to the quality control of traditional Chinese medicine A person who is engaged in the extraction of traditional Chinese medicine told reporters that the new regulations mean that all traditional Chinese medicine enterprises must build their own raw material extraction production lines The enterprises with their own raw material extraction workshops will not be affected basically Those small enterprises that purchase raw materials will be greatly affected, and will face the situation of production suspension or merger "For small enterprises, it is a good opportunity to stop production; for large enterprises, it is a good opportunity to merge and integrate." The new raw material production line of traditional Chinese medicine faces the problem of high cost According to the above insiders, for the new TCM raw material production line, the investment in the new workshop should be at least 5 million yuan According to the new GMP standard, an additional investment of at least 3 million yuan is needed For the most basic configuration of the extraction equipment, at least 3 million yuan is needed For the standardization of the technological process, another 23 million yuan is needed In this way, the total cost is close to 15 million yuan For an enterprise with an annual purchase amount of 20 million yuan of raw materials, they need at least two years of profits for the investment of raw materials factory, while many small traditional Chinese medicine enterprises spend millions of yuan on the purchase of raw materials every year, with large investment in raw materials extraction workshop However, due to small size and small demand, the cost will be higher than the previous outsourcing, which is basically a loss The draft for comment on canceling the "drug number" of Chinese herbal extracts also indicated that the provincial food and drug administration would not register the Chinese herbal extracts with the drug number after the expiration of the approval number However, the effective components or effective parts of traditional Chinese medicine from new drugs shall be managed according to the chemical raw materials, except for the approval number of varieties for production and use of chemical preparations Wei Shaofeng, Deputy Secretary General of China Pharmaceutical Materials Association, told reporters that for some time, there had been suggestions from the industry to cancel the approval number management of Chinese herbal extracts and encourage pharmaceutical enterprises with the ability to produce Chinese herbal extracts Wei Shaofeng said that for a long time, some traditional Chinese medicine manufacturers have been unable to produce traditional Chinese medicine extracts because they do not have the production approval number of traditional Chinese medicine extracts, while some of the enterprises with the approval number of traditional Chinese medicine extracts have small production and some do not Due to the great market demand, some enterprises of Chinese herbal extracts are purchased from the market and then sold on the brand, which leads to the lack of sufficient guarantee of the quality uniformity between batches of products, the greater risk of product quality, and the greater difficulties in supplier management, GMP certification and other aspects for Chinese herbal manufacturers The draft encourages competent Chinese medicine manufacturers to produce their own Chinese medicine extracts, which will change the situation that enterprises in need cannot produce due to no approval number, and enterprises with approval number have small output or even do not produce Chinese herbal extracts will be put on record for management According to the draft for comments, Chinese patent medicine manufacturers should make clear the quantity, flow direction and use of drug residues, establish a traceable registration file, and take measures such as destroying the shape of drug residues that can be separated from complete medicinal materials or pieces of decoction to prevent them from flowing into the circulation of medicinal materials or pieces of decoction According to the insiders, the national pharmacopoeia stipulates that the raw materials of traditional Chinese medicine must be Chinese herbal pieces, that is, processed Chinese herbal medicines However, there are many abnormal phenomena that the price of Chinese herbal pieces is lower than that of Chinese herbal medicines in the current market, among which the reason is adulteration According to Chen qiguang, a researcher at the Institute of Economic Research of the Academy of Social Sciences and executive director of the research group of traditional Chinese medicine of the Academy of Social Sciences, many "modern Chinese medicine" manufacturers that lack business ethics reprocess and slice the raw materials of traditional Chinese medicine that have been extracted as "effective ingredients" and "monomers" and then sell them to the drug market in the form of decoction pieces, Beijing Evening News reported It makes the Chinese patent medicine produced by many pharmaceutical factories with this kind of "decoction pieces" greatly reduce the efficacy, or even completely fail Along with the opinions, there are also annexes to the detailed rules for the record management of Chinese herbal extracts According to the attachment, the State Food and Drug Administration will be responsible for establishing the filing information platform for Chinese herbal extracts The enterprise producing the Chinese herbal extract shall record through the information platform of the Chinese herbal extract, including the name of the Chinese herbal extract, the enterprise producing the Chinese herbal extract, the name of the Chinese patent medicine varieties using the Chinese herbal extract, the approval number, the manufacturer and other information