CFDA: Notice on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese Medicine

Sfjyhj [2014] No 135: the approval of the entrusted processing of extraction of traditional Chinese medicine will be stopped from the date of issuance of the notice If it has been approved, it can continue to December 31, 2015 Since January 1, 2016, all Chinese patent drug manufacturers without the ability to extract traditional Chinese medicine will stop the production of corresponding varieties The detailed announcement is as follows: the food and Drug Administration of each province, autonomous region and municipality directly under the Central Government: the extraction and extraction of traditional Chinese medicine is the premise and material basis to ensure the quality control, safety and effectiveness of traditional Chinese medicine In recent years, with the large-scale and intensive development of traditional Chinese medicine production, the problems in the extraction or outsourcing of traditional Chinese medicine extracts are more prominent, which brings hidden dangers to the quality and safety of traditional Chinese medicine In order to strengthen the supervision and management of extraction and extract of traditional Chinese medicine, standardize the production behavior of traditional Chinese medicine, and ensure the quality safety and effectiveness of Chinese patent medicine, the relevant provisions are hereby notified as follows: first, extraction of traditional Chinese medicine is the key link in the production and quality management of Chinese patent medicine, and the production enterprise must have the extraction ability suitable for its product type and scale Pharmaceutical manufacturers can set up pre-treatment and extraction workshops in different places, or share pre-treatment and extraction workshops with pharmaceutical manufacturers with holding relationships within the group 2、 If a Chinese patent medicine manufacturing enterprise needs to set up a pretreatment or extraction workshop in another place, it shall be approved by the food and Drug Administration of the province (District, city) where the enterprise is located The establishment of non local workshops across provinces (regions and cities) shall also be examined and approved by the food and Drug Administration of the province (region and city) where the workshop is located The production address of the workshop in another place shall be indicated on the drug production license of the Chinese patent medicine manufacturer 3、 If the pre-treatment and extraction workshop is shared by the pharmaceutical manufacturers with a holding relationship within the group, the workshop shall belong to a pharmaceutical manufacturer within the group, and shall be reported to the local food and Drug Administration for approval The establishment of a shared workshop across provinces (regions and cities) shall be subject to the examination and approval of the food and Drug Administration of the province (region and city) where both parties are located The group should strengthen unified management, clarify the responsibilities of both parties, formulate practical production and quality management measures, and establish strict quality control standards The name and address of the enterprise to which the extraction workshop belongs shall be indicated on the pharmaceutical production license of the Chinese patent medicine manufacturer sharing the extraction workshop 4、 The manufacturer of Chinese patent medicine shall be responsible for the pre-treatment or extraction quality of the relevant varieties in the different workshop or shared workshop, incorporate them into the production and quality management system and manage the whole process of production, and the extraction process shall conform to the production process of the produced Chinese patent medicine The extraction process should correspond to the batch of Chinese patent medicine, form a complete batch production record, and take effective quality control measures in storage, packaging, transportation, etc The enterprises affiliated to the shared workshop shall organize production in accordance with the GMP, strictly implement the quality agreement between the two parties, and be responsible for the quality of the extraction process 5、 The food and Drug Administration of the province (District, city) where the Chinese patent medicine manufacturing enterprise is located is responsible for the supervision and management of the production process of the corresponding varieties of different workshops or shared workshops The extended supervision shall be carried out for the different workshops or shared workshops across the province (District, City) The food and Drug Administration of the province (District, city) where the workshop is located is responsible for the daily extraction process of the different workshops or shared workshops Supervision 6、 From the date of issuance of this notice, the food and Drug Administration of all provinces (regions and cities) shall stop the examination and approval of the entrusted processing of traditional Chinese medicine If it has been approved, it can continue to December 31, 2015 During this period, the food and Drug Administration of each province (District, city) shall strengthen the supervision and management of the approved entrusted processing, urge the entrusting party to fulfill its responsibilities in accordance with the requirements of the GMP, formulate feasible quality assurance system and management measures, establish controllable quality standards such as the content determination or fingerprint of the extracted products from the entrusted processing, and carry out the production of the whole process of the entrusted processing Carry out quality monitoring and technical guidance, and take effective measures in the transportation process to ensure the quality of commissioned processing In case of any non-compliance with the requirements, the approval of the entrusted processing shall be revoked and no separate approval shall be allowed Since January 1, 2016, all Chinese patent medicine manufacturers without the ability to extract traditional Chinese medicine will stop the production of corresponding varieties 7、 For the Chinese patent medicine, the national drug standard prescription items shall be downloaded, and the Chinese herbal extracts with separate national drug standards shall be put on record 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) 8、 Chinese patent medicine manufacturers should strictly follow the drug standards for feeding production, and be responsible for the quality of Chinese herbal extracts For the Chinese herbal extracts that belong to the filing management, they can be extracted by themselves or purchased and used; for the Chinese herbal extracts that do not belong to the filing management, they should be extracted by themselves Since January 1, 2016, Chinese patent medicine manufacturers are not allowed to purchase the unreported traditional Chinese medicine extract for production 9、 The production enterprises of Chinese herbal extracts on record shall organize production in accordance with the requirements of GMP to ensure the quality of their products, and their daily supervision shall be in the charge of the food and Drug Administration of the province (District, city) where they are located As of the date of printing and distributing this article, the production enterprises of traditional Chinese medicine extracts shall not issue the drug production license and the drug GMP certificate If the license has been issued, it shall not be reviewed and issued again after the expiration of the validity period 10、 If the Chinese patent medicine manufacturing enterprise uses the registered Chinese herbal extract for production, it shall conduct quality assessment and supplier audit on the Chinese herbal extract manufacturing enterprise in accordance with the GMP requirements The food and Drug Administration of the province (District, city) where the Chinese patent medicine manufacturer is located shall organize and carry out extended inspection on the manufacturers of Chinese herbal extracts in accordance with the relevant requirements of the GMP and the national drug standards, and issue an inspection report to confirm whether they meet the requirements of the GMP 11、 The extract of traditional Chinese medicine will no longer be managed according to the approval number, except for the effective ingredients and parts of traditional Chinese medicine approved according to new drugs After the expiration of the validity period of the original approval number, the food and Drug Administration of each province (District, city) will not accept the re registration application for the Chinese herbal extracts which have obtained the drug approval number and should be included in the record management according to the provisions of this notice 12、 Pretreatment of traditional Chinese medicine is an important process in the production of traditional Chinese medicine Traditional Chinese medicine production enterprises and traditional Chinese medicine extract production enterprises shall have facilities and equipment for pretreatment of traditional Chinese medicine corresponding to the varieties they produce, formulate corresponding pretreatment process procedures, and process and process traditional Chinese medicine If the raw materials of Chinese herbal pieces are purchased for production, they must be purchased from the production and operation enterprise of Chinese herbal pieces with legal qualification 13、 If a Chinese patent medicine manufacturer violates the provisions of Article 7 of this circular and uses the unreported Chinese herbal extract for production, it shall investigate and deal with it in accordance with Article 79 of the drug administration law of the people's Republic of China 14、 If the manufacturer of Chinese patent medicine fails to feed and produce according to the provisions of drug standards, and purchases and uses Chinese herbal extracts instead of Chinese herbal pieces, it shall be punished as fake drugs according to the second paragraph of the third paragraph of Article 48 of the drug administration law of the people's Republic of China 15、 This notice shall be implemented as of the date of issuance In case of any inconsistency between the previously issued relevant documents and this notice, this notice shall prevail The above requests the food and Drug Administration of each province (District, city) to notify the relevant drug manufacturers in the administrative region and follow the implementation If there are any problems and suggestions during the implementation of this document, please report them to the General Administration in a timely manner State Food and Drug Administration July 29, 2014