The new drug law has just implemented a special flight inspection!

Finishing: dishishsinan The new drug administration law was officially implemented on December 1, 2019 In order to further regulate the production behavior of Jilin traditional Chinese medicine injection enterprises, prevent and control risks, and identify hidden dangers, the official website of Jilin Drug Administration issued the notice of Jilin drug administration on printing and distributing (jjjf [2019] No 212) The notice requires Jilin Inspection Branch to carry out on-site supervision and inspection on the production enterprises of traditional Chinese medicine injection by means of flight inspection from December 1, 2019 to June 15, 2020, and organize and carry out the special rectification of the production enterprises of traditional Chinese medicine injection within the whole city of Jilin The special rectification is organized and implemented in three steps, with four key contents As a unique drug in China, traditional Chinese medicine injection is widely used in clinical practice, even in flood In 2015, Shengmai injection of Jiangsu Suzhong Pharmaceutical Co., Ltd was forced to recall by the drug regulatory department due to the adverse reaction symptoms such as shivering after injection After this incident, traditional Chinese medicine injection companies were once again concerned by the public Since the implementation of the new drug administration law, Jilin Provincial Food and drug administration has taken the lead in carrying out the special renovation of Chinese medicine injection drug production enterprises nationwide, ensuring the safety and legal rights and interests of the public, supervising the implementation of the main responsibilities of enterprises, eliminating quality risks, improving the production and management level of Chinese medicine injection, ensuring the quality and safety of Chinese medicine injection production, establishing and improving Chinese medicine injection The long-term supervision mechanism ensures the safety and legal rights and interests of the public in drug use, and comprehensively investigates the risks and hidden dangers in all aspects of the production of traditional Chinese medicine injection If there are any untruths, the enterprise is willing to bear all the legal liabilities arising therefrom Step 1: self check and self correction The enterprise is required to complete self inspection and self correction before November 30, 2019, formulate risk prevention and control measures, and submit the self inspection report; Second, supervision and inspection Jilin Inspection Branch will carry out on-site supervision and inspection on the production enterprises of traditional Chinese medicine injection by means of flight inspection from December 1, 2019 to June 15, 2020, check the self-examination and self correction of the enterprises, and seriously investigate and deal with the illegal problems and clues found in accordance with the law; Step 3: summarize the assessment After the completion of supervision and inspection, Jilin Inspection Branch will comprehensively analyze and assess the risk, determine the supervision level, inspection focus and inspection frequency of the enterprise before June 25, 2020, in view of the existing problems of the enterprise First, whether the enterprise organizes the production of traditional Chinese medicine injection in strict accordance with the pharmaceutical production quality management specifications Focus on checking whether the enterprise has established and improved the drug production quality management system, and whether the drug production process continues to meet the legal requirements; Second, whether the traditional Chinese medicine injection organizes drug production and inspection according to the national standard or approved production process It is important to check whether the enterprise feeds materials strictly according to the prescription ingredients and whether the feeding amount is consistent with the actual batch requirements; Whether there is any unauthorized addition of Chinese herbal extracts or chemical components, Chinese herbal medicines (Chinese herbal pieces) are not fed or less fed, and whether the extracts with content requirements are converted into feeds; Whether the pre-treatment processing of medicinal materials is carried out according to the regulations, and whether the content of the pre-treatment processing record is true and complete and traceable; Whether the water for extraction of traditional Chinese medicine injection meets the requirements; Whether the extracted dregs are treated according to the procedures; Third, whether the raw materials and auxiliary materials required for production meet the requirements and whether the supplier audit system is strictly implemented It is important to check whether the sources of Chinese herbal medicines and extracts of Chinese herbal medicines are legal, whether fake and inferior Chinese herbal medicines are used, whether non-medical parts of Chinese herbal medicines are used, whether direct smashed powder is purchased to replace Chinese herbal medicines, and whether polluted or extracted Chinese herbal medicines are used to produce drugs; Whether the purchased Chinese herbal extracts have legal qualification; Fourth, whether the packaging materials and containers of the drugs directly contacted by the enterprise meet the pharmaceutical requirements Article 25 of the new drug administration law: when examining and approving drugs, the drug regulatory department under the State Council shall review and approve the chemical raw materials, relevant auxiliary materials, packaging materials and containers in direct contact with drugs, and the quality standards, production processes, labels and instructions of drugs Article 125 of the new drug administration law: Whoever, in violation of the provisions of this law, commits one of the following acts, confiscates the illegally produced and sold drugs, illegal income, packaging materials and containers, orders to stop production and business for rectification, and also imposes a fine of not less than 500000 yuan but not more than 5 million yuan; if the circumstances are serious, the drug approval certificate, drug production license and drug trade shall be revoked For a license, the legal representative, the main person in charge, the directly responsible person in charge and other persons in charge shall be fined not less than 20000 yuan but not more than 200000 yuan, and shall be prohibited from engaging in drug production and marketing activities for ten years or even for life: (2) producing drugs or selling such drugs by using unapproved packaging materials or containers that have direct contact with drugs;