The safety of generic drugs is concerned, and the life cycle of drugs will be strictly regulated

[pharmaceutical Station industry trends] China is a big country of generic drugs, more than 95% of which are generic drugs Based on the huge quantity of products in the generic drug market, there may be dozens or even hundreds of drugs produced by different enterprises under the same generic name of drugs However, the production capacity and technical level of these drug manufacturers are uneven, and the product quality lacks objective and unified standards, which leads to frequent safety accidents of generic drugs How to ensure the safety of generic drugs is highly valued by relevant departments Attention In order to improve the quality of generic drugs and ensure the drug safety of patients, in April 2016, China implemented a consistency evaluation policy for generic drugs across the country According to the principle of consistency with the quality and efficacy of the original research drugs, the approved generic drugs were evaluated in stages and batches, so that the quality and efficacy of the generic drugs and the original research drugs reached the same level It is reported that the varieties passing the consistency evaluation are printed with striking blue marks on the drug packaging boxes Doctors and patients can judge whether the drug quality is reliable and whether it can be used safely through this mark At present, the consistency evaluation policy of generic drugs has been continuously promoted, which has ushered in a major reshuffle of the generic drug industry, promoted the overall development of the industry in the direction of high quality, the generic drug market has shown explosive growth, and spawned a number of leading generic enterprises with high-quality production level In 2018, the consistency evaluation of generic drugs involving 4238 varieties accelerated According to the regulations, the generic drugs in the "289 catalog" must complete the conformity evaluation before December 31, 2018, otherwise the chance of being purchased by medical institutions will be lost However, due to the fact that China's generic drugs are mainly small and medium-sized enterprises, the start-up rate of the generic drug consistency evaluation program is not ideal, and the time limit for China has been relaxed to three years In addition, in 2019, the "4 + 7" volume procurement policy also benefits the development of high-quality generic drugs and innovative drugs, and it is expected that the pharmaceutical market pattern will change in the future It is understood that for the winning varieties of "4 + 7" volume procurement, the drug administration will take more strict measures to supervise the life cycle of drugs and ensure the safety of patients' medication
For example, the notice of the State Food and Drug Administration on strengthening drug supervision during the pilot period of centralized purchase and use of drugs mentioned that for the winning drugs, in terms of production, the regulatory department is required to strengthen the on-site inspection of the varieties, especially the winning drug manufacturing enterprises, through the conformity evaluation of generic drugs, and focus on the implementation of the responsibility of enterprise risk potential investigation The implementation of production quality management specifications, the authenticity and reliability of data, the strict implementation of raw and auxiliary material quality control, and the strict control of source quality risk In terms of circulation, it is required to strengthen the supervision of circulation and use, supervise and urge the distribution units of the winning drugs to strictly implement the requirements of the drug trade quality management specifications, supervise and urge the medical institutions to continue to comply with the requirements, and ensure the quality and safety of the winning drugs in circulation and use At the same time, it is also required to actively promote the production enterprises of the winning varieties to speed up the construction of the informatization traceability system in accordance with the guidance of the State Food and Drug Administration on the construction of the informatization traceability system, so as to ensure that the whole process of the winning varieties can be traced before the end of 2020
In addition, it is required to do a good job in monitoring, reporting, analysis and evaluation of adverse reactions, fully implement the main responsibility of drug safety of the enterprise; strengthen the quality supervision over the production, circulation and use cycle of the winning varieties, increase the punishment of the illegal enterprises, urge the winning enterprises to establish the enterprise inventory and stop production reporting system, standardize the distribution behavior through agreements, and ensure the drug Product supply.