[Zhou Jun] the General Administration has been focusing on the clinical trial data of these 35 drugs, and the introduction of in vitro dissolution of varicose in Shanghai bidding raises questions

The State Administration of food and Drug Administration will verify the clinical trial data of 35 drug registration applications On January 26, the State Administration of food and Drug Administration issued the announcement of the State Administration of food and Drug Administration on the application of self inspection and verification of drug clinical trial data According to the announcement, CFDA has received 35 applications for registration of drugs that have completed clinical trial application for production or import submitted by 17 pharmaceutical companies, including Pfizer, MSD and AstraZeneca, and has decided to check the clinical trial data At the same time, the General Administration issued a notice that: before the inspection organized by the General Administration, if the applicant for drug registration finds that there is a authenticity problem in the data of drug clinical trials through self inspection, he / she shall voluntarily withdraw the application for registration, and the General Administration will not pursue his / her responsibility after publishing his / her list The General Administration's public information catalogue is coming, which concerns every medical person! On January 26, the General Administration of food and Drug Administration issued the basic catalogue of government information active disclosure China's official account of the 1 food and drug administration, 2 WeChat general public, "Chinese food medicine", 3 "General Administration micro-blog" "China food and drug supervision", 4 general mobile client "China food and drug supervision", 5 news conference, 6 other news media The requirements for the application materials of phase I clinical trials of new drugs are here on January 25 The General Administration issued the technical guidelines for the application of phase I clinical trials of new drugs, which are applicable to innovative drugs and improved new drugs, including chemicals and biological products for treatment (excluding cell and gene therapy products) It is worth noting that before submitting the application for clinical trial of new drugs, the applicant can apply for holding a pre application meeting with the drug audit center according to the methods and working procedures specified in the administrative measures for communication and exchange of drug research and development and technical review In terms of API information, the complete address of API manufacturer (including production and inspection) shall be submitted In terms of preparation information, the prescription composition and dosage of the preparation shall be listed, and the components used in the preparation process but finally removed shall also be listed The excipients in the preparation shall meet the pharmaceutical requirements; for the new excipients that have not been used in the preparation at home and abroad, the related declaration shall be made From next month, the application for registration of class 1 chemicals shall be subject to ICH level II guidelines On January 25, CFDA announced that it decided to apply the secondary guiding principles of five international human drug registration technology coordination meetings (ICH): M4: General technical documents for human drug registration applications (CTD), E2A: management of clinical safety data: definition and standard of quick report, E2d: management of post marketing safety data: definition and standard of quick report, M1: regulatory activity medicine MedDRA, e2b (R3): clinical safety data management: data elements of individual safety report transmission From February 1, 2018, M4: General technical document for registration of human drugs (CTD) is applicable to registration applications of chemical drugs classified as category 1, 5.1, biological products for treatment and biological products for prevention Drug regulatory upgrading: on January 24, the state will build five major drug regulatory key laboratories, and the General Administration issued the master plan for key laboratories, which will plan five types of drug regulatory key laboratories in the fields of traditional Chinese medicine, chemicals, biological products, packaging materials and auxiliary materials and key technologies of Interdisciplinary 92 GMP certificates were withheld by the General Administration! On January 25, the General Administration issued the statistical table of the withdrawal of GMP certificates in 2017 In 2017, 157 GMP certificates were recovered nationwide, 65 of which have been returned In terms of provinces, Guangdong received the most certificates, with 16 certificates; Jilin followed, with 13 certificates; Henan, Guangxi and Gansu ranked third, with 11 certificates each In addition, in 2017, three provinces did not receive certificates, namely Heilongjiang, Tibet and Xinjiang The problems found in the inspection involve data reliability such as recording and deleting modified data, nonstandard document records, disordered material management, and absence of key administrators From the perspective of recycling enterprises, traditional Chinese medicine enterprises are still the objects of key inspection and certificate collection Is it good or bad to introduce in vitro dissolution curve in Shanghai bidding for pharmaceutical events? Recently, the third batch of drugs in Shanghai has been purchased through centralized bidding The difference in this purchase is the introduction of multiple in vitro characteristic dissolution curve assessment indicators and review requirements The document indicates that if the manufacturer has completed the dissolution test in accordance with the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs, the relevant materials shall be submitted for review In the subsequent notice on review of relevant matters, three materials are mainly provided: the established dissolution method, comparison results with reference preparations, evaluation criteria and method validation (including mechanical calibration of dissolution instrument) As soon as this assessment and review requirement is issued, it has aroused heated discussion in the industry It is believed that this requirement can play an effective role in the supervision of drugs Through the in vitro dissolution materials provided, it can better predict the quality and efficiency of drugs Some people also questioned whether the evaluation standard for the efficacy of generic drugs is mainly be, because there is a situation of bioequivalence in vivo even if the dissolution in vitro is inconsistent, and whether this requirement has the suspicion of being willing to give up A large number of pharmaceutical enterprises in Jiangxi have been cancelled! On January 22, Jiangxi food and Drug Administration announced that Jiangxi Kangfeng Pharmaceutical Co., Ltd was cancelled due to the expiration of the validity period of the drug trade license and the failure to apply for the renewal of the license before the expiration of the validity period According to incomplete statistics, in 2017, 48 Enterprises' drug trading licenses were cancelled in Jiangxi Province, including 28 cancelled by the Provincial Bureau and 20 by the Municipal Bureau Most of the reasons for cancellation are enterprise applications, and some enterprises have been cancelled due to the expiration of the certificate According to statistics of Beijing News, from January 1, 2017 to January 17, 2018, the IPO audit announcement released by the official website of China Securities Regulatory Commission showed that 52 medical and pharmaceutical enterprises went on the IPO meeting, 41 of which passed the examination successfully and 11 failed In addition, it also includes 14 enterprises that have terminated the review due to active application or failure to respond to the feedback on schedule Industry insiders said that most of the termination of the audit stage is active application for termination or failure to respond to feedback on schedule The reporter of Beijing News found that some of the enterprises that had terminated the review had been accused of abnormal operation, and some had burst out product quality problems, environmental protection problems, etc Be careful! The 9 batches of drugs produced by 9 enterprises are unqualified after being inspected by 9 drug inspection institutions such as CFDA, and are marked as 9 batches of drugs produced by 9 enterprises such as Shenzhen Hanyu Pharmaceutical Co., Ltd Unqualified items include character, content determination, disintegration time limit, weight difference, loading difference, paste content and potency determination For the above-mentioned unqualified drugs, the relevant provincial food and drug supervision and administration departments have taken control measures such as sealing up and detaining, requiring the enterprises to suspend the sale and use of the products, recall the products, and carry out rectification The highest level of generic drugs, a thorough impact on 4500 pharmaceutical companies! On January 23, the second meeting of the leading group for comprehensively deepening reform of the Central Committee deliberated and adopted several opinions on reforming and improving the supply guarantee and use policy of generic drugs It was pointed out at the meeting that we should focus on clinical necessity, accurate curative effect, shortage of supply, prevention and treatment of major infectious and rare diseases, disposal of public health emergencies, children's drug use, etc., promote research and development innovation of generic drugs, improve quality and curative effect, and improve the ability of drug supply guarantee The documents adopted at the meeting have not yet been published, but combing the policies on generic drugs issued by the past countries can find the key points to improve the quality and give priority to the use According to relevant data, more than 90% of China's generic pharmaceutical enterprises, that is to say, there are more than 4500 generic pharmaceutical enterprises The implementation of this policy will completely affect the fate of these enterprises Health industry will be supported by intellectual property On January 23, the catalogue of key supporting industries of intellectual property (2018 version) issued by the State Intellectual Property Office clarified the top ten key industries that are the key development of the state and need intellectual property support, among which the supported health industries specifically include five directions: major new drug development, important disease prevention and control and precision medicine, high-end medical devices, modernization of traditional Chinese medicine and intelligent medicine Amazing! Sun Qiang, a researcher at the Institute of neuroscience, Chinese Academy of Sciences, announced in Beijing Thursday afternoon that after five years of unremitting efforts, the team has broken through the world's difficult problem of somatic cell cloning monkeys and successfully bred the world's first individual cell cloning monkey This marks that China will take the lead in opening the era of macaque as an experimental animal model The results were published online as a cover article in cell, a leading academic journal of biology, on January 25 Southwest University and Chongqing pharmaceutical exchange both entered the pharmaceutical intelligence network to seek cooperation in the direction of pharmaceutical big data On January 23, Hu Changhua, Dean of the school of pharmacy of Southwest University, signed a strategic cooperation agreement with Shi Yuanping, founder of yaozhi.com, which includes the construction of "virtual system of medical information retrieval", "database of authentic medicinal materials and compounds in Chongqing", "database of Chinese medicinal materials and compounds" and the installation of trial version of yaozhi.com of Southwest University Meanwhile, the school of pharmacy of Southwest University is in yaozhi.com The professional practice base for postgraduates with master's degree of Southwest University was established, and professors Li Tianquan and Wang Gang, CO founders of yaozhi.com, were employed as part-time professors of Southwest University On January 26, Ao Rongfeng, general manager of Chongqing pharmaceutical exchange, and his delegation came to yaozhi.com for investigation and reached preliminary intention on data mining and in-depth cooperation on forum cooperation Sanofi's US $11.6 billion acquisition of biooverativ recently revealed that Sanofi will purchase all outstanding shares of biooverativ with us $105 per share in cash, totaling about US $11.6 billion Biooverativ is a biopharmaceutical company focusing on hemophilia and other rare blood disease therapies Sanofi will further promote the RNAi therapy for hemophilia A A and B with its professional clinical knowledge and existing platform This is a new drug under development with global development and commercialization rights from Alnylam.