A traditional Chinese medicine successfully challenged the conclusion of CDE evaluation, but it was planted in clinical self-examination

On April 1, 2016, CFDA released the list of 181 clinical self checking drugs in the second batch, among which naoxinduotai capsule (acceptance No.: cxzr130010) jointly declared by Tianjin HongRi Pharmaceutical Co., Ltd., Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of medicine, Chinese Academy of Sciences was included Naoxinduotai capsule is the reexamination application of the fifth class production registration application of traditional Chinese medicine submitted by HongRi pharmaceutical industry The clinical research of this kind of capsule was completed by Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of medicine, Chinese Academy of Sciences After clinical self-examination, Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of pharmaceutical research of Chinese Academy of Sciences decided to withdraw the product voluntarily After careful consideration, the company submitted the application for withdrawal of registration application of naoxinduotai capsule to Tianjin market and quality supervision and Administration Committee recently The relevant information is as follows: 1 Basic information of the drug Drug name: naoxinduotai capsule dosage form: capsule specification: 0.232g per capsule (containing Tribulus terrestris saponin 10mg) application items: Chinese medicine category 5 production registration application reexamination application applicant: Tianjin HongRi Pharmaceutical Co., Ltd., Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine, Shanghai Institute of medicine, Chinese Academy of Sciences acceptance No.: cxzr130010 indications It has the functions of calming the liver, promoting blood circulation, regulating qi and phlegm, and promoting Bi and Tong Yang It is mainly used to treat apoplexy, hemiplegia, numbness of limbs, chest Bi, vertigo, headache, etc 2、 Naoxinduotai capsule is a hospital preparation from Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine In June 2000, naoxinduotai capsule was jointly applied for clinical research by Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine, Shanghai Institute of medicine of Chinese Academy of Sciences, Xiamen Jianfa Pharmaceutical Co., Ltd (later renamed Xiamen Xingsha pharmaceutical Co., Ltd.) Clinical approval was obtained in March 2004, and clinical research was completed in September 2007 In September 2009, Xiamen Xingsha Pharmaceutical Co., Ltd., Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of medicine, Chinese Academy of Sciences transferred the research results of this product to HongRi pharmaceutical In February 2011, HongRi pharmaceutical, Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of medicine of Chinese Academy of Sciences jointly applied for production registration In January 2013, HongRi pharmaceutical received the notice of approval opinions issued by CFDA and did not approve the production registration application of the product In April 2013, HongRi pharmaceutical, Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine and Shanghai Institute of pharmaceutical research of Chinese Academy of sciences applied to CFDA for reexamination of production registration application of naoxinduotai capsule In July 2014, CFDA drug review center decided to correct the original review conclusion and conduct technical review again according to the results of the 41st batch of review varieties working meeting Before the withdrawal, as of the end of May, the net book value of development expenditure of naoxinduotai capsule was 4.0757 million yuan HongRi pharmaceutical said that the initiative to withdraw the above drug registration application is a prudent decision made in combination with the latest review and approval policy on Drugs issued by the State Food and drug administration.