Anhui: carry out the filing of traditional Chinese medicine preparation

In order to implement the "one network one door one time" government service plan of Anhui Province, promote the "one network one time" government service, and do a good job in the filing of traditional Chinese medicine preparation for medical institutions, according to the notice of the former State Food and Drug Administration on the filing management of traditional Chinese medicine preparation for medical institutions (No 19, 2018), the following According to the requirements of the announcement, Appendix 1), the Provincial Bureau has developed the "Filing platform for Anhui medical institutions to prepare traditional Chinese medicine preparations with traditional technology" and embedded it in the Anhui government service network From now on, we will officially carry out the filing work of traditional Chinese medicine preparation in Anhui medical institutions Now the relevant matters are announced as follows: 1 Visit "Anhui government affairs service network" (https://www.ahzwfw.gov.cn/), click the "login" button at the top right of the page to log in to the platform with the legal person account If there is no account, you need to click the "register" button to register as a legal person first If you have any questions, please contact Anhui government affairs service network user registration and real name authentication service Tel.: 0551-12345 2、 After logging in successfully, you can search the item name of "medical institutions apply traditional technology to prepare traditional Chinese medicine preparation for filing" directly through the search box at the bottom of the home page navigation, enter the details page of the item, click "online processing" to apply online; you can also click the navigation menu "work guide", search "Anhui food and Drug Administration" in "department service", search This matter See attachment 2 for detailed operation 3、 According to the relevant requirements of the announcement, fill in the form related to the applicant and the application for traditional Chinese medicine preparation filing item by item, and print the filing application form that can be automatically generated by the system Then, the filing application form and other filing materials shall be stamped with the official seal of the medical institution and scanned into PDF files, which shall be uploaded to the acceptance system in the form of attachments, and submitted after confirmation After passing the preliminary examination, submit the registration form of traditional Chinese medicine preparation prepared by medical institutions and a complete set of original registration materials to the Provincial Bureau window to complete the acceptance work Four The Provincial Bureau shall, within 30 working days after receiving the filing materials, publicize the filing number and other information in the special area of the bulletin board "filing of traditional technology preparation of traditional Chinese medicine" on the website of the Provincial Bureau, and the medical institutions shall inquire on their own and obtain the filing number before preparing If it does not meet the requirements, it shall not be filed and shall be informed in the filing system 5、 The prescription of traditional Chinese medicine preparation for filing shall not be changed, and other filing information shall not be changed at will For the traditional Chinese medicine preparations that have been put on record, if the information affecting the quality of preparations such as the standards of traditional Chinese medicine, the standards of Chinese medicine pieces or processing specifications, processing and production technology (including auxiliary materials), packaging materials, internal control agent standards, preparation address and the entrusted preparation unit is changed, the medical institution for filing shall submit the description of the change, relevant supporting documents and research data, as shown above The procedure shall be changed for filing After the completion of the change filing, the traditional Chinese medicine preparation will obtain a new filing number, and the medical institution can implement the change content If other information is changed, the filing number shall not be changed 6、 Before January 10 of each year, the annual report of the last year of the filed varieties shall be submitted through the filing platform, including changes, clinical use data, quality status, adverse reaction monitoring, etc After the completion of the annual report filing, the filing number of traditional Chinese medicine preparation will remain unchanged If there is any problem in the process of applying traditional technology to prepare traditional Chinese medicine preparation for filing, please contact the administrative examination and approval Office of the Provincial Bureau Contact: Cui Ying (0551-62999869), Chu Yan (0551-62999793) Notice is hereby given Annex: 1 Announcement on the filing management of traditional Chinese medicine preparation by medical institutions (click to read the original text and view the annex) 2 Operation guide of traditional Chinese medicine preparation by medical institutions in Anhui Province (click to read the original text and view the annex) Anhui food and Drug Administration October 11, 2018 (open attribute: active disclosure)