Is the peak of cancellation of drug approval number in 2019 coming? 85 approvals completely withdrawn from the market

On April 4, 2019, the State Drug Administration issued a notice to cancel 85 drug approval numbers of Changchun Changsheng Biotechnology Co., Ltd and other companies, including 53 drug approval numbers due to the active application of enterprises, 13 drug approval numbers due to the revoked drug approval documents It is worth noting that 19 drug approval numbers were cancelled due to Changchun Changsheng Biotechnology Co., Ltd Technology Co., Ltd was revoked the drug production license according to law On the same day, the official website of the State Drug Administration announced that 85 drug approval numbers had been cancelled at one go On the one hand, it was the result of market competition On the other hand, it released a signal that the drug regulatory authorities were increasingly strict with the safety production management of drugs in 2019, and a large number of drug approvals were cancelled in 2019 1、 According to the current version of the measures for the administration of drug registration (Order No 28), the cancellation of drug approval documents can be divided into six situations: (1) the validity period of approval documents is not yet expired, and the applicant proposes to cancel the drug approval number on his own; （2） Refusing to re register in accordance with the provisions of Article 126 of the measures for the administration of drug registration; (3) the drug production license has been revoked or revoked according to law; （4） In accordance with the provisions of Article 42 of the drug administration law and Article 41 of the regulations for the implementation of the drug administration law, revoking the approval certificate for drugs with serious adverse reactions or other reasons endangering human health; (5) making a decision on administrative penalty for revoking the approval certificate according to law; （6） Other circumstances in which the drug approval certificate shall be revoked or withdrawn according to law 2、 Analysis of the cancellation types of 85 cancelled drug approval numbers, there are four main types of cancellation types, namely: It is reported that in 2018, Chongqing pharmaceutical regulatory bureau cancelled the drug production license and GMP certificate of Chongqing Hanhua Pharmaceutical Co., Ltd due to the merger of enterprises In addition, 15 of the 19 are approval numbers of imported drugs According to law, 18 drug production licenses have been revoked, all of which are Changchun Changsheng's vaccines and Thymosin injection varieties 13 drug approval documents have been revoked, which are compound preparations containing furazolidone The drug production license has been revoked according to law and one of the drug approval documents has been revoked It is the freeze-dried human rabies vaccine (Vero cell) variety of Changchun Changsheng in 2018 The production of this variety has illegal behaviors such as record fraud, which has been investigated by the relevant departments, the GMP of drugs has been confiscated and the drug production license has been revoked 3、 Analysis of 85 cancelled drug approval numbers, involving 53 varieties, accounted for the largest proportion of the two-dimensional furazolidone tablets and gaddafusemide injection varieties, with 7 approvals cancelled respectively Four, cancel the drug approval document dosage form analysis of 85 cancelled drug approval number, cancel the distribution according to the dosage form statistics, there are 9 main categories, namely, 28 tablets, 28 injections, 12 raw materials, 10 capsules, 2 liniment, freeze-dried powder injection / injection of aluminum hydroxide suspension 2, gel 1, diagnostic reagent 1, and injection solution 1 5、 Distribution of pharmaceutical enterprises with cancelled drug approval number According to the distribution of provinces, the 85 cancelled drug approval numbers are 34 in Chongqing, 24 in Liaoning, 3 in Guizhou, 2 in Jiangsu, 1 in Gansu, 1 in Hainan, 1 in Henan, 1 in Shandong, 1 in Shanxi, 1 in Sichuan and 1 in Tianjin In addition, four foreign-funded drug enterprises have applied for the cancellation of drug approval numbers of 15 products 6、 Future outlook More and more attention has been paid to the effectiveness, safety and quality controllability of drugs by China's drug regulatory authorities Over the past three years, tens of thousands of drug approval numbers have been cancelled in China In 2019, it is believed that the drug regulatory authorities at all levels will spare no effort to implement the four strictest standards, the strictest supervision, the strictest punishment and the strictest accountability of the CPC Central Committee If there is any violation of these four strictest standards It is also one of its destiny to be forced to cancel the drug approval number in violation of laws and regulations Of course, after the baptism of strict supervision, most pharmaceutical enterprises will be more standardized, more in line with the provisions of the drug production quality management specifications, hoping that the number of drug approval numbers to be cancelled will be less and less Reference [1] http:// [2] mp.weixin.qq.com/s/m7mxpbwj8hf26lswsxhegq [3] xueqiu.com/5964803315/124600332 Annex I directory of cancelled drug approval number