Food and Drug Administration: Chinese patent medicine manufacturers are not allowed to purchase unreported Chinese herbal extracts for production

The notice of the State Food and Drug Administration on strengthening the supervision and administration of extraction and extract in the production of traditional Chinese medicine clearly stipulates that from January 1, 2016, all the Chinese patent medicine manufacturers shall not purchase the unreported traditional Chinese medicine extract for production However, the implementation of the policy is imminent As for whether some varieties need to be put on record, the author understands that not only the enterprises can not make accurate judgments, but also some provincial and municipal competent bureaus have not yet fully understood the national policy and told the enterprises that further research is needed Some varieties will face policy dilemma On July 29, 2014, the State Administration issued the notice of the State Food and Drug Administration on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (sfjyhjj [2014] No 135 document and the annex implementation rules for the record management of traditional Chinese medicine extraction), which clearly defined the traditional Chinese medicine extraction That is, to download the prescription items of national drug standards of Chinese patent medicine, and to implement the record management of Chinese herbal extracts with separate national drug standards All pharmaceutical manufacturers that produce or use the above-mentioned Chinese herbal extracts shall file in accordance with the detailed rules for the implementation of the filing management of Chinese herbal extracts (see Annex) Article 2 of the detailed rules for the implementation of the filing management of Chinese herbal extracts: the Chinese herbal extracts referred to in these detailed rules are the prescription items of the national drug standards of Chinese patent medicine, and have the independent national drug standards, and are used for the volatile oil, oil, extract, liquid extract, dry extract, effective ingredients, effective parts and other components of the Chinese patent medicine feeding production The Chinese herbal extracts referred to in these detailed rules do not include: the Chinese patent medicine national drug standard has specific preparation method or standard extracts; the Chinese herbal effective ingredients or effective parts approved by new drugs; borneol, indigo naturalis, donkey hide gelatin and other traditional products used by Chinese herbal medicines or Chinese herbal pieces; berberine hydrochloride and other products managed by chemical APIs and chemically modified It can be seen from the above that 47 varieties under the catalogue of "vegetable oil and extract" in 2010 and 2015 edition of Chinese Pharmacopoeia and the standards of Chinese herbal extracts approved by the State Food and drug administration belong to the category of Chinese herbal extracts, and the record management should be implemented in accordance with the document provisions The specific list of 47 extracts of traditional Chinese medicine included in Chinese Pharmacopoeia 2015 is as follows: Clove basil oil, star anise oil, ginseng stem leaf total saponin, ginseng total saponin, Notoginsenoside, Notoginsenoside, rhubarb flow extract, rhubarb extract, hawthorn leaf extract, patchouli oil, Salvia miltiorrhiza total phenolic acid extract, tanshinone extract, buffalo horn concentrated powder, liquorice flow extract, liquorice extract, Beidou root extract, angelica flow extract, cinnamon oil, lamp Scutellarin, yuanzhiliu extract, Forsythia Extract, Vitex oil, Cyclovirobuxine D, turpentine oil, acanthopanax senticosus extract, bergenin, sarcandra extract, wormwood extract, tea oil, xiangguozhi, Jiangliu extract, andrographolide, zedoary oil, eucalyptus oil, asiaticoside, Leonurus extract, Zhebei extract, Scutellaria extract, huangteng, gingko leaf extract, sesame oil , castor oil, mangrove oil, menthol oil, menthol, belladonna liquid extract, belladonna extract Which Chinese herbal extracts have approval number, should they be filed? Although Document No 135 has made it clear that no document number management will be implemented for Chinese herbal extracts, except for the effective ingredients or parts approved according to new drugs, it is impossible to know exactly which Chinese herbal extracts belong to the effective ingredients or parts approved according to new drugs According to the notice, except for the effective ingredients or parts of traditional Chinese medicine approved in accordance with the new drug, other products of traditional Chinese medicine extracts previously given approval number will not be registered at the expiration of the validity period of the original approval number, and the drug production license and GMP certificate will not be issued at the same time According to the relevant standards, among the 47 varieties of traditional Chinese medicine extracts collected in 2010 and 2015, there are 24 varieties with approval number management: Clove basil oil, star anise oil, Notoginsenoside, total Notoginsenoside, rhubarb extract, buffalo horn concentrated powder, liquorice extract, liquorice extract, angelica extract, cinnamon oil, breviscapine, Polygala extract, Cyclovirobuxine D, turpentine, acanthopanax senticosus extract, bergenin, ginger extract, andrographolide, zedoary oil, eucalyptus oil, asiaticoside , Leonurus extract, menthol, belladonna extract However, it is impossible to know exactly which variety of Chinese herbal extracts under the management of these 24 approval numbers conforms to the effective components or parts of Chinese herbal medicines approved according to new drugs, and which does not conform to the effective components or parts of Chinese herbal medicines approved according to new drugs Because the documents and attachments do not specify which extracts are to be filed according to the filing management and which ones are to be filed according to the new drug management, production and use departments, while the regulatory department thinks that there is an approval number not to be filed All of these, when the time limit comes, make some regulatory departments and production and use departments confused and confused, which is not conducive to the effective implementation of the policy, let alone Conducive to the good development and monitoring of the industry 7 varieties that need to be confirmed to have impact on the industry Due to the limited data at hand, the author is unable to accurately determine which are the effective ingredients or parts of traditional Chinese medicine approved by the state in accordance with the new drug standard However, according to the preliminary judgment of the standards under the varieties of Pharmacopoeia 2015 and the situation of the production enterprises, it is particularly necessary to further confirm whether the following varieties are reviewed in accordance with the new drug standard Batch of products: clove basil oil, Cyclovirobuxine D, bergenin, andrographolide, asiaticoside, zedoary oil, cinnamon oil and other seven varieties 1 The production of clove basil oil raw materials involves three existing production enterprises As the raw materials of compound clove basil oil preparation, it involves eight preparation production enterprises As the raw materials of preparation Zhengjin oil (ointment), it involves two enterprises As the raw materials of red Zhengjin ointment, it involves three enterprises; 2 The raw material production of Huanwei huangyangxing D involves three existing production enterprises As the raw material of preparation Huangyangning tablet, it involves eleven preparation production enterprises; 3 The raw material production of Bergenin involves 9 manufacturing enterprises, and the preparation product compound bergenin tablet involves 54 manufacturing enterprises, and the approval number of the drug substance is zxxxxxxx (for example, bergenin: z53021700, Yunnan Baiyao Group Co., Ltd.), but the approval number of the preparation is zxxxxxxx (for example, compound bergenin tablet) : gyzz z53021695 Yunnan Sansheng Pharmaceutical Co., Ltd.; 4 6 raw material enterprises approved by chemical drugs (gyzz hxxxxxx) for andrographolide; 6 production enterprises approved by traditional Chinese medicine extract (gyzzxxxxx); Andrographolide is used as the raw material of preparation products The preparation products approved by zxxxxxxx: andrographolide tablet involves 14 enterprises, andrographolide capsule involves 2 enterprises, andrographolide dropping pill involves 1 enterprise, andrographolide soft capsule involves 4 enterprises, and andrographolide dispersible tablet involves 2 enterprises; 5 There are 2 enterprises involved in the production of asiaticoside raw materials and 12 enterprises involved in the preparation of asiaticoside tablets; 6 The raw materials of zedoary turmeric oil involve two manufacturing enterprises, among which the raw material approval number of Dazhou natural plant Pharmaceutical Co., Ltd is Guoyao Zhun Zi z20053002, involving 17 compound zedoary oil suppositories and 7 compound zedoary oil soft capsules of corresponding preparation products; the raw material approval number of Zhejiang Tianrui Pharmaceutical Co., Ltd is Guoyao Zhun Zi h33021759, involving the injection of zedoary oil of preparation products There are 14 liquid products, 38 zedoary turmeric oil and glucose injection products; 7 There are 2 enterprises involved in cinnamon oil raw materials, and 26 enterprises involved in preparation of safflower oil and safflower oil products The above raw materials, especially curcuma oil, are the raw materials of Curcuma oil injection and curcuma oil glucose injection According to the public data, the sales volume of Curcuma oil glucose injection alone in 2014 was more than 600 million If raw materials cannot be filed or registered, there may be problems with the supply of these drugs In some cases, the author consulted the information published on the website of the State Administration for filing enterprises, which showed that at present, there are 331 enterprises filing the use of extracts, among which several enterprises have successfully filed the use of clove basil oil, zedoary turmeric oil and cinnamon oil The product "dragon's blood" with the national drug standard and approval number was collected in the 22nd volume of the new drug registration standard, and has 8 approval numbers, involving 8 raw material manufacturers The raw material is used in the preparation production of dragon's blood tablet, powder, capsule and lozenge, involving 12 confidant enterprises The dragon's blood of the original raw material manufacturer has been produced by a Guangdong company The company has successfully filed and publicized However, in other places, whether these varieties are recorded or not remains to be further confirmed Since "since January 1, 2016, Chinese patent medicine manufacturers are not allowed to purchase the unreported traditional Chinese medicine extract for production", it has to cause the high attention and active follow-up of the traditional Chinese medicine extract manufacturers and users, especially the traditional Chinese medicine extract manufacturers with new drug certificates, so as to prevent unnecessary losses to their own enterprises 。 At the same time, it is also suggested that the General Administration of China should issue supplementary documents or implementation instructions in time, so as to guide the local drug supervision and administration departments, production enterprises, user enterprises and other links to actively, steadily and effectively carry out the production, use and record management of Chinese herbal extracts on the basis of unified standards and knowledge.