On September 5, at the State Council’s regular policy briefing, Zeng Yixin, Deputy Director of the National Health Commission, and other officials answered questions from reporters on issues related to the National Essential Medicines List.

　　In this round of formulary adjustments, equal emphasis was placed on both additions and deletions, as well as on Western and traditional Chinese medicines. A total of 187 drugs were added, while 22 were removed, increasing the overall number of items in the formulary from the original 520 to 685, including 417 Western medicines and 268 proprietary Chinese medicines.

　　The drugs removed from the formulary are primarily those for which clinically viable alternatives already exist, or those associated with frequent adverse reactions, uncertain therapeutic efficacy, or gradual phasing-out in clinical practice.

　　In addition, generic versions of essential medicines that have not passed the consistency evaluation will be gradually removed from the formulary.

　　The National Essential Medicines List is subject to dynamic adjustments, in principle no more than once every three years. For newly launched drugs that have demonstrated clear efficacy, reasonable pricing, and superior therapeutic outcomes compared with existing medications, the adjustment process shall be initiated in a timely manner to include them on the list.

　　The National Essential Medicines List prioritizes the clinical value of drugs—those that can cure diseases or substantially and sustainably improve patients’ quality of life—and places particular emphasis on aligning the list with the evaluation of bioequivalence and therapeutic equivalence for generic drugs. It underscores the need to systematically prioritize the inclusion of drug varieties that have passed such evaluations in the Essential Medicines List. According to reports, more than half of the drug varieties that have undergone bioequivalence evaluation have been included in the list, while cost-effectiveness is also taken into account.

　　Building on coverage of major clinical indications, the focus is on cancers, pediatric conditions, and chronic diseases. New additions include 12 anti-tumor agents, 22 urgently needed pediatric medicines, and the world’s first—and China’s only—fully oral, pan-genotypic, single-tablet direct-acting antiviral agent for hepatitis C, as recommended by the World Health Organization.

　　Compared with previous editions, the 2018 National Essential Medicines List took into account that the essential medicines system had already achieved full coverage in government-run primary-level medical institutions, and that allowing local authorities to supplement the list was a transitional measure adopted during the early stages of institutional development. This time, the guidelines clearly stipulate that, in principle, localities are no longer permitted to add drugs to the list. In March 2013, the health authorities released a new edition of the National Essential Medicines List. The revised list expanded the number of items, including 317 chemical drugs and biological products and 203 traditional Chinese patent medicines, for a total of 520—213 more than the original list. Given the insufficient coverage of the essential medicines system, national policy allowed local governments to supplement the list. However, the process of such supplementation revealed significant problems. Provinces such as Xinjiang, Chongqing, Guizhou, Guangdong, Jiangxi, and Qinghai each added more than 200 items to their supplementary lists. In some provinces, the supplemented lists included a large number of locally produced drugs and exclusive formulations. Subsequently, the nation was shocked by the “Guangdong Essential Medicines Supplementation Corruption Case.”

　　The explicit stipulation this time that, in principle, no further additions will be made at the local level can, to a certain extent, curb opportunities for rent-seeking through the abuse of power.

　　The National Essential Medicines List places greater emphasis on seamless alignment with medical insurance reimbursement policies, while also taking into account the needs of public health disease prevention and control. Specifically, therapeutic drugs included in the list are subject to a streamlined procedure: when the medical insurance authorities revise the national reimbursement directory, eligible drugs will be prioritized for inclusion or reclassified from Category A to Category B, thereby gradually enhancing the level of actual coverage and minimizing patients’ out-of-pocket drug expenses to the greatest extent possible.

　　By implementing centralized bulk procurement to reduce drug prices and promoting rational drug use to lower costs, while ensuring adequate financial and insurance support, local authorities are encouraged to prioritize the use of essential medicines in the management of chronic diseases such as hypertension, diabetes, and severe mental disorders—provided that therapeutic efficacy is maintained—thereby gradually enhancing the actual coverage and affordability of essential medicines and encouraging patients to choose them.

　　Drugs that have been included in the National Essential Medicines List must undergo price negotiations to be further added to the national medical insurance reimbursement list, with prices reduced to a reasonable level. At the same time, comprehensive random inspections will be conducted across all varieties of essential medicines, and oversight and inspection of the production process will be strengthened, so as to provide patients with safe, quality-assured, and trustworthy medications. These measures primarily include:

　　I. Random Inspections: The Drug Administration conducts random inspections of all varieties of essential medicines.

　　II. In the production stage, conduct end-to-end inspections of essential medicines.

　　III. Emphasize Improving Drug Quality.

　　IV. Establish a drug quality淘汰 mechanism: products that have passed the consistency evaluation shall be gradually included in the National Essential Medicines List, while those that have not passed the evaluation shall be phased out at an appropriate time.

　　V. Special attention shall be given to the monitoring of adverse reactions associated with essential medicines; the next step will focus on clinical-use monitoring and comprehensive clinical evaluation of these drugs.

　　The next step is the official release of the 2018 National Essential Medicines List.