177 over evaluated varieties have been verified, and the drugs will face the whole process of supervision

[industry trends of pharmaceutical network] drug safety is related to the national economy and the people's livelihood Only by doing well in drug supervision according to the requirements can we promote social co governance to ensure drug safety Recently, at the launch ceremony of national drug safety month 2019 and the fourth China drug safety forum, Wang Xiaogang, director of the food and drug audit and inspection center of the State Drug Administration, disclosed a group of data: in recent years, a total of 27 countries and 154 varieties of drugs have been subject to on-site inspection of overseas production, of which 21 varieties have been announced, suspended from import and sales And use, no re registration and other administrative processing, and 20 varieties are known to be included in the overseas inspection, the enterprise voluntarily withdraw the examination, withdraw the examination, or even give up the variety number According to statistics, from January to September of this year, the verification center has completed the clinical trial data verification of 163 varieties and the on-site inspection of 177 varieties of drugs In addition, it has carried out the on-site inspection of overseas production of drugs for 154 varieties in 27 countries, a total of 331 varieties, which have been verified to ensure the safety of drug use In fact, since 2019, both at home and abroad, countries and regions have been increasing their supervision on drugs At the press conference of the second session of the 13th National People's Congress in March, the State Administration of market supervision and the state drug administration responded to the concerns of the people about food safety, counterfeit and shoddy products, health products, drug safety and other issues Among them, strict supervision will be adopted in key areas such as food and drug, children's supplies, and elderly supplies, which are of great concern to the masses and cause great harm In July 2019, the general office of the State Council issued the opinions on the establishment of professional drug inspectors It is planned that by the end of 2020, the drug regulatory department of the State Council and the provincial drug regulatory department will basically complete the construction of professional drug inspectors system In the recently revised Drug Management Law, in order to strengthen the supervision and management of drug production, GMP / GSP certification was also cancelled, which means that the supervision mode of pre approval has gradually transformed into dynamic in process and post supervision, and the whole life cycle supervision mode has been basically established At a press conference held by relevant departments on July 17, the work plan for special actions of national procuratorial organs, market regulatory authorities and drug regulatory authorities to implement the "four strict" requirements for food and drug safety showed that, in view of vaccine safety issues, it is necessary to strengthen the supervision and law enforcement of vaccine drugs and prevent vaccine quality risks from the source To achieve the high frequency and full coverage of the inspection of vaccine manufacturers, it is also necessary to punish the relevant responsible person and pursue the responsibility and punishment to the individual It is necessary to take integrity punishment measures jointly with relevant departments, and prohibit the illegal from entering the industry   Recently, Shanxi health and Health Commission also published the detailed rules for the management of clinical use of key controlled and rational drugs (chemical and biological products) in Shanxi Province, among which 18 kinds (categories) and 21 drugs are restricted, including: ganglioside, cerebroside, oxiracetam, sodium creatine phosphate, calf serum deproteinization, Alprostadil, troxerutin cerebroprotein hydrolysate, complex coenzyme , Danshen Ligustrazine In fact, the revision of drug administration, the establishment of key monitoring catalogue, the establishment of drug inspectors, the adoption of ranking notification, rectification within a time limit, the elimination of the drug supply catalogue of the agency, and the reform of the centralized procurement mode are all to solve some problems in the development of the pharmaceutical industry in the past 。 These policies and regulations indicate that in the future, the state will pay more attention to the whole process of drug supervision For example, the revised draft of the drug administration law specifies the traceability requirements for drug quality and safety, and the drug listing license holders, production and operation enterprises and medical institutions shall establish and implement strict traceability system to ensure the authenticity, accuracy, integrity and traceability of the data in the whole process For example, in the process of vaccine development, production, circulation and vaccination, information technology should be used to collect and retain traceability information Through the release of these policies and regulations, some insiders said that the era of strict control of the pharmaceutical industry is coming.