The general office of the General Administration of the people's Republic of China issues the notice on the registration of the preparation of traditional Chinese medicine preparations by applying traditional techniques in medical institutions

Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government, and food and Drug Administration of Xinjiang production and Construction Corps: Announcement on the filing management of the application of traditional technology in the preparation of traditional Chinese medicine preparations for medical institutions (Announcement No 19, 2018 of the State Food and drug administration, hereinafter referred to as the "announcement") has been issued on February 9, 2018 In order to carry out the implementation of the announcement and make the filing work of traditional Chinese medicine preparation (hereinafter referred to as traditional Chinese medicine preparation) prepared by medical institutions in an orderly manner, the relevant matters are hereby notified as follows: 1 Each provincial bureau shall, in accordance with the requirements of the announcement, promptly complete the construction of the traditional Chinese medicine preparation filing information platform The filing information platform shall be able to automatically generate the information required in the registration form of traditional Chinese medicine preparation prepared by medical institutions with traditional technology, give full play to the role of social supervision, and automatically disclose the basic filing information such as the name of traditional Chinese medicine preparation, the name of medical institutions, filing time, filing number, preparation process line, adverse reaction monitoring, etc The internal control quality standards, prescriptions, auxiliary materials, process parameters and other materials involving trade secrets shall not be disclosed 2、 All provincial bureaus shall take the initiative to publicize the spirit and specific requirements of the announcement, organize the training of relevant medical institutions in the administrative region in a timely manner, make it clear that the medical institutions shall bear the responsibility for the quality management of traditional Chinese medicine preparations in the whole process, and take the overall responsibility for the safety and effectiveness of the recorded varieties 3、 Food and drug supervision and administration departments at all levels shall strengthen the in-process and post-mortem supervision of the recorded varieties, take the recorded information as an important basis for supervision and inspection, and strictly inspect the sources, processing, preparation, use and other links of the used medicinal materials In case of non-compliance with the provisions of Article 16 of the announcement, the filing information shall be cancelled in time, and the illegal cases shall be investigated and dealt with seriously according to law 4、 All provincial bureaus shall coordinate the connection between the examination and approval of traditional Chinese medicine preparation varieties and the filing For the varieties that have been accepted, the applicant may choose to apply for withdrawal and go through the filing procedure instead; for the varieties that have obtained the approval number, each provincial bureau shall study in advance and sort out the relevant varieties and their files After the expiration of the validity period of the approval number of the relevant varieties, the filing management shall be carried out for those that meet the requirements 5、 All provincial bureaus shall strictly implement the relevant requirements of the announcement, and may formulate detailed rules for implementation in combination with local conditions Major problems found in the process of filing shall be reported to the General Administration in a timely manner.