The National Healthcare Security Administration (NHSA) has released the “Work Plan for the National Reimbursement Drug List (NRDL) Update, 2023”, following an earlier draft proposal for this year’s NRDL update. The document contains no significant surprises and aligns with the rules used for the 2022 update.
Eligibility and Update Rules for 2023
The update rules for this year are largely consistent with those used in 2022. Eligible for inclusion are any innovative drugs approved from January 1, 2018, to June 30, 2023. Additionally, there are no restrictions on the approval date for children’s medicines and rare disease drugs.
New Elements in the 2023 Update
Compared to the previous feedback document, the novelties include a postponement of time requirements for drug approval and modification of indications. Drugs approved for marketing or modification of indications after January 1, 2018, can be filed. COVID-19 therapeutic drugs are no longer listed separately but are to be declared normally. The adjustment process has been optimized in terms of expert review, data templates, and informatization. Furthermore, there is a promise to strengthen supervision and management of enterprise behavior, with dishonest behavior such as violations of laws and regulations to be linked to the management of the NRDL.
Work Process and Timeline
According to the document, the work process for this year is divided into five stages: preparation, application, expert review, negotiation, and publication of results. The process is set to initiate on July 1, 2023, with negotiations and results expected in November. From July 1, 2023, the online filing system will be accessible for companies on the National Healthcare Security Administration’s official service platform at https://fuwu.nhsa.gov.cn/.-Fineline Info & Tech
