Chinese medicine enterprises or face raw materials out of stock!


Release time:

2015-12-29


The Notice of the State Food and Drug Administration on Strengthening the Supervision and Administration of Extracts and Extracts in the Production of Traditional Chinese Medicine clearly stipulates that from January 1, 2016, Chinese patent medicine manufacturers shall not purchase unfiled traditional Chinese medicine extracts for production.
However, the implementation of the policy is imminent. As to whether some varieties need to be put on record, the author understands that not only enterprises can not make accurate judgments, but also some provincial and municipal administrations have not yet thoroughly understood the national policy and are not sure, telling enterprises that further research is needed. Some varieties will face policy dilemmas as a result.
47 extracts that need to be filed
On July 29, 2014, the State Administration of Food and Drug Administration issued the Notice of the State Food and Drug Administration on Strengthening the Supervision and Administration of Extracts and Extracts in the Production of Traditional Chinese Medicine (Document No. 135 of the State Food and Drug Administration and Drug Administration [2014] and the Annex "Implementation Rules for the Filing Management of Chinese Medicine Extracts" clearly defined Chinese medicine extracts.
That is, the Chinese patent medicine national drug standard prescription item download, and has a separate national drug standard of traditional Chinese medicine extract to implement the record management. All pharmaceutical manufacturers that produce or use the above-mentioned Chinese medicine extracts that should be filed shall file in accordance with the Implementation Rules for the Filing Management of Chinese Medicine Extracts (see Annex).
Article 2 of the Implementation Rules for the Filing Administration of Chinese Medicine Extracts:
The traditional Chinese medicine extract referred to in these rules is the prescription item of the national drug standard of Chinese patent medicine, and has a separate national drug standard, and is used for the production of Chinese patent medicine feeding volatile oil, grease, extract, liquid extract, dry extract, effective ingredients, effective parts and other ingredients.
The extracts of traditional Chinese medicine referred to in these rules do not include: extracts with specific preparation methods or standards in the national drug standards of proprietary Chinese medicines; Effective ingredients or effective parts of traditional Chinese medicines approved according to new drugs; Borneol, indigo naturalis, donkey-hide gelatin and other traditional Chinese medicines or products used in Chinese herbal pieces; Berberine hydrochloride and other products managed according to chemical raw materials and chemically modified.
From the above, it can be seen that the 47 varieties under the 2010 edition of the Chinese Pharmacopoeia and the 2015 edition of the first catalogue "Plant Oil and Extracts" and the standards of traditional Chinese medicine extracts approved by the State Food and Drug Administration all belong to the category of traditional Chinese medicine extracts and should be put on record management in accordance with the provisions of the documents. The specific list of 47 traditional Chinese medicine extracts collected in the 2015 edition of Chinese Pharmacopoeia is as follows:
Clove basil oil, star anise oil, ginseng stem leaf total saponins, ginseng total saponins, panax notoginseng saponins, panax notoginseng total saponins, rhubarb extract, rhubarb extract, hawthorn leaf extract, patchouli oil, salviae miltiorrhizae total phenolic acid extract, tanshinone extract, licorice root extract, cyrrhizae rhizae rhizae root extract, D extract, rhizae rhizae root extract, rhizae root extract, cinnamum extract, rhizae rhizae extract, wormwood extract, camellia oil, balsam, ginger extract, andrographolide, zedoary oil, eucalyptus oil, Centella asiatica total glycosides, motherwort extract, Zhejiang shellfish extract, scutellaria baicalensis extract, palmatine, ginkgo leaf extract, sesame oil, castor oil, mandarin red oil, peppermint oil, menthol, belladonna extract, belladonna extract.
Which Chinese herbal extracts have approval numbers and should they be filed?
Although document No. 135 has made it clear that traditional Chinese medicine extracts are no longer subject to document number management, except for the effective ingredients or parts of traditional Chinese medicine approved according to new drugs, it is impossible to know exactly which traditional Chinese medicine extracts belong to the effective ingredients or parts of traditional Chinese medicine approved according to new drugs.
According to the notice, except for the effective ingredients or parts of traditional Chinese medicine approved according to the new drug, the rest of the products with the approval number of traditional Chinese medicine extract before shall not be registered when the validity period of the original approval number expires, and the "drug production license" and "drug GMP certificate" shall not be issued at the same time.
According to the relevant standards, of the 47 varieties of traditional Chinese medicine extracts collected in the 2010 and 2015 editions, 24 have approval number management:
Clove basil oil, star anise oil, panax notoginseng saponins, panax notoginseng saponins, rhubarb extract, buffalo horn concentrated powder, licorice extract, liquorice extract, angelica extract, cinnamon oil, breviscapine, polygala extract, cyclovirocerine D, turpentine oil, acanthopanax extract, celadine, menisinolide, cinolide.
However, it is impossible to know exactly which of the 24 traditional Chinese medicine extracts managed by the approval number conforms to the effective ingredients or parts of traditional Chinese medicine approved according to the new drug, and which does not conform to the effective ingredients or parts of traditional Chinese medicine approved according to the new drug.
Because the documents and attachments do not specify which extracts are subject to filing management and which are subject to new drug management, production and use departments, while the regulatory authorities think that there are approval numbers that are not subject to filing, all these have left some regulatory departments and production and use departments in a state of confusion and confusion when the deadline comes, which is not conducive to the effective implementation of policies and is not conducive to the good development and monitoring of the industry.
Seven varieties that need to be identified as having an impact on the industry.
Due to the limited information on hand, the author cannot accurately judge which are the active ingredients or parts of traditional Chinese medicines approved by the state according to the new drug standards. However, according to the standards under various varieties of the 2015 edition of the pharmacopoeia and the preliminary judgment of the production enterprises, it is especially necessary to further confirm whether the following varieties are products approved according to the new drug standards: clove basil oil, cycloviridae D, bergenin, andrographolide, asiaticoside, zedoary oil, cinnamon oil and other 7 varieties.
1, clove basil oil raw material production involves the existing three production enterprises, as the compound clove basil oil preparation raw material medicine, involving eight preparation production enterprises;
2. The production of Huanwei Huangyang Star D raw material involves three existing production enterprises. As the raw material medicine of preparation Huangyangning Tablets, it involves eleven preparation production enterprises;
3. The production of Bageenan raw materials involves 9 production enterprises, and the preparation product compound Bageenan tablet involves 54 preparation production enterprises, and the approval number of the raw material drug is Zxxxxxxxx to the national drug standard) (e.g. Bageenan: Z53021700 to the national drug standard, Yunnan Baiyao Group Co., Ltd.), but the approval number of the preparation is all Zxxxxxxxx to the national drug standard (e.g. compound Bageenan tablet: Yunnan Sansheng Pharmaceutical Co., Ltd., Z53021695);
4. There are 6 raw material enterprises approved by the chemical medicine of andrographolide (Chinese medicine standard Hxxxxxxxx); There are 6 production enterprises approved by the traditional Chinese medicine extract as the raw material (Chinese medicine standard Zxxxxxxxx);
Andrographolide is used as the raw material of preparation products, and the preparation products approved by the Chinese medicine standard Zxxxxxxxx: andrographolide tablets involve 14 enterprises, andrographolide capsules involve 2 enterprises, andrographolide dripping pills involve 1 enterprise, andrographolide soft capsules involve 4 enterprises, and andrographolide dispersible tablets involve 2 enterprises;
5. The production of Centella asiaticoside raw materials involves 2 enterprises, and the preparation product snow glycoside tablets involves 12 enterprises;
6. Zedoary turmeric oil raw materials involve 2 manufacturers, of which Dazhou Natural Plant Pharmaceutical Co., Ltd. has a raw material approval number of Z20053002, involving 17 compound zedoary turmeric oil suppositories and 7 compound zedoary turmeric oil soft capsules. Among them, Zhejiang Tianrui Pharmaceutical Co., Ltd. has a raw material approval number of H33021759, involving 14 zedoary turmeric oil injections and 38 zedoary turmeric oil glucose injections;
7, cinnamon oil raw materials involved in 2 enterprises, preparation is safflower oil, safflower oil products involved in 26 enterprises.
The above raw materials, especially zedoary turmeric oil, are the raw materials of zedoary turmeric oil injection and zedoary turmeric oil glucose injection. Public data show that the sales volume of zedoary turmeric oil glucose injection alone in 2014 was more than 0.6 billion. If the raw materials cannot be filed or registered, it may cause problems for the supply of these drugs.
Cases in some areas
The author consulted the public information of enterprises filing on the website of the State Administration of China, showing that there are currently 331 enterprises filing the use of extracts, of which several enterprises have successfully filed the use of clove Basil oil, zedoary turmeric oil and cinnamon oil. In addition, it is found that the product "dragon's blood" with national drug standard and approval number is contained in volume 22 of the new drug confirmation standard, and has 8 approval numbers, involving 8 raw material production enterprises. the raw material is used for the preparation production of dragon's blood tablets, powder, capsules and buccal tablets, involving 12 bosom friends enterprises. dragon's blood of the original production enterprise of the raw material has been successfully filed and publicized by a Guangdong manufacturer producing dragon's blood capsule.
However, in other places, whether these varieties are filed remains to be further confirmed. Due to the hard lever that "since January 1, 2016, Chinese patent medicine manufacturers are not allowed to purchase unfiled Chinese medicine extracts for production", it has to arouse the high attention and active follow-up of Chinese medicine extract manufacturers and users. In particular, Chinese medicine extract manufacturers with new drug certificates should actively do so to guard against unnecessary losses to their own enterprises.
At the same time, it is also suggested that the State Administration of the people's Republic of China can issue supplementary documents or implementation instructions in a timely manner, so as to correctly guide local drug supervision and administration departments, production enterprises, user enterprises and other links to actively, steadily and effectively carry out the record management of the production and use of Chinese medicine extracts on the basis of unified standards and unified understanding.