In January of this year, experts reported during the Shanghai Two Sessions that certain centrally purchased drugs may have quality risks. Relevant departments quickly dispatched personnel to investigate and understand the situation. Recently, relevant officials from the medical insurance and drug supervision departments who participated in the survey were interviewed by reporters on how to further ensure the quality of centrally purchased drugs. Comrades from the medical insurance and drug supervision departments have stated that the continuous practice since 2018 has not only enabled the centralized procurement policy and centralized procurement drugs to undergo clinical testing, but also enabled the mainstream medication of Chinese patients to achieve a leap from "unapproved generic drugs" to "overrated generic drugs". But compared to the expectations of the general public, there are still areas that need to be continuously improved in the work. For example, selected pharmaceutical companies can be further urged to proactively disclose drug quality data to society. For example, we can further respond to the general concerns of society in a more down-to-earth way, effectively resolving doubts and doubts. The quality assurance of drugs requires long-term effort and continuous effort, always maintaining the spirit of "rushing to the test" on the road. Next, relevant departments will continue to make efforts in the following aspects to ensure the quality of centrally purchased drugs. One is to continuously strengthen the supervision and management of drug quality. Quality is the lifeline of drugs. The drug regulatory department will continue to benchmark international technical standards, strictly conduct technical evaluations and post market change management, continuously publicly disclose evaluation reports in accordance with laws and regulations, adhere to full coverage inspections of selected enterprises in centralized procurement and full coverage sampling of selected varieties, urge enterprises to continue compliant production, promptly dispose of drugs and enterprises with problems found, and publicly disclose regulatory information in accordance with the law. At the same time, timely report relevant information to the medical insurance department on whether quality risks are found in the daily supervision of centralized procurement drugs. Secondly, we will continue to encourage frontline clinical doctors to make good use of the adverse drug reaction monitoring information platform and actively provide feedback on drug quality risk clues. The drug regulatory and medical insurance departments encourage doctors to timely and accurately detect and collect suspected adverse reactions of drugs, and report them to the "National Adverse Drug Reaction Monitoring System" in accordance with relevant laws and regulations. The drug regulatory department will organize evaluations based on relevant information, investigate and handle according to law, and further publicize to medical institutions and personnel, fully protecting the privacy of adverse reaction reporters and dispelling concerns about proactive reporting. At the same time, it also encourages relevant personnel in the pharmaceutical industry and various sectors of society to continuously supervise the quality of drugs. Thirdly, we will continue to encourage and support clinical medical staff and medical institutions to leverage their professional expertise, promote professional spirit, and conduct clinical research in a scientific and standardized manner. Medical insurance, drug supervision and other departments support relevant medical institutions and medical staff, especially authoritative medical institutions such as national medical centers and regional medical centers, to conduct real-world research on original drugs, generic drugs that have passed consistency evaluation, etc., to examine drug efficacy on a larger scale, highlight regulatory priorities, promote industry development, and enable high-quality drugs to benefit a wider range of patients. (New Society)
Edit:Chen Jie Responsible editor:Li Ling
Source:People's Daily
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