CCTV News: According to the National Medical Insurance Administration, the National Medical Insurance Administration issued a "Letter on Please Assisting to Listen to Related Opinions on Collected Drugs in Face-to-face". Recently, during the Shanghai Two Sessions, some CPPCC members and medical experts reported that some collective drug products may have quality risks and other issues, and the National Medical Insurance Administration attached great importance to it. On the 21st, the National Health Insurance Administration will work with the health, industrial informatization and drug regulatory departments to go to Shanghai to listen to opinions and suggestions from relevant CPPCC members and experts on drug procurement policies and the quality assurance of selected products, and focus on collecting clues about quality and efficacy issues supported by clinical data and statistical differences.

Exchange outline

1. Introduction to the basic policies and quality assurance of centralized drug procurement. Reliable quality is a prerequisite for the inclusion of drugs in centralized procurement; reference preparations (mainly original drugs), as well as generic drugs that have passed the quality and efficacy consistency evaluation organized by the national drug regulatory authorities can be included in the scope of centralized procurement. The centralized procurement will be filled in by medical institutions across the country to purchase the quantity to be purchased, and enterprises will independently compete for quotations. After the election, the procurement agreement will be signed. The medical insurance department urges the selected enterprises to ensure supply according to the agreement. The volume of centralized procurement agreements is generally between 60% and 80% of the reported volume of medical institutions. The remaining part is independently selected by medical institutions to purchase brands. Without the "one-size-fits-all" system arrangement, the procurement and use of "imported original drugs" is not allowed. The evaluation of the quality and efficacy consistency of generic drugs and the participation of hospitals in research and trials is introduced. All bidding companies in centralized procurement have passed the consistency evaluation and have received random inspections of 100% full coverage of enterprises and varieties by the drug supervision department. This introduces the real-world research on selected drugs conducted by more than 80 tertiary hospitals covering more than 300,000 patients. The disposal of selected drugs for individual quality problems is introduced.

2. In-depth verification of the effectiveness of clinical use of centralized procurement drugs. Listen to the clinical frontline feelings about the effectiveness of the selected drugs used in centralized procurement, and focus on collecting cases where there are differences in efficacy and safety indicators such as cure rate, treatment efficiency, and adverse reaction incidence, and there are statistically significant and traceable case information. According to the differences and changes of the general name of the drug, dosage form, specifications, selected company name, effectiveness and safety information (such as systolic blood pressure and diastolic blood pressure values ​​for anti-tumor drugs, progression-free survival, recurrence and metastasis rates, glycated hemoglobin compliance rates for lowering blood sugar, fasting blood sugar compliance rates, liver and kidney function indicators, etc.), a list of problem clues will be summarized and formed, and it will be formally handed over to the drug quality supervision and management department. At the same time, we should understand the specific situations of the untimely supply of some selected drugs reported by relevant experts, resolutely urge the selected enterprises to correct the problem, and deal with the matter if it cannot be corrected in a timely manner according to the tender agreement.

3. Discuss opinions and suggestions on further ensuring the quality and effectiveness of centralized procurement drugs. If there are indeed quality problems with centralized procurement drugs, the medical insurance department will resolutely hold the selected enterprises accountable in accordance with the centralized procurement agreement and relevant systems, including but not limited to the cancellation of the selected qualification, inclusion on the list of centralized procurement violations, and giving a breach of trust rating. At the same time, we jointly discussed and discussed effective ways to further ensure the quality and effectiveness of centralized drug procurement, including three suggestions from the Shanghai Municipal Committee of the China Democratic League reported by the media, such as requesting the competent drug quality supervision department to strengthen daily inspections after the drug passes consistency evaluation, fully publicizing the results of bioequivalence tests for the consistency evaluation of generic drugs, and establishing feedback and collection channels for evidence of drug efficacy comparison in medical institutions.