On May 31, 2024, China's National Healthcare Security Administration (NHSA) announced the issuance and implementation of the Procedures for Determining the Inclusion of Drugs in the National Reimbursement Drug List (Trial) (hereinafter referred to as "Procedures").
The Procedures address cases in which discrepancies arise in the names or dosage forms of drugs, such as those caused by renaming, which differ from the listings in the NRDL. In these instances, stakeholders believe that, according to the NRDL's related provisions, these drugs should be identified as either included in or excluded from the NRDL.
The determination process involves four key stages: application submission, application confirmation, expert review, and result publication.
1. Application Submission: Pharmaceutical companies, medical institutions, and other stakeholders disputing the classification of drugs in the NRDL can submit an application to the Medical Service Management Department of the NHSA. The submission must include an application form and supporting documents, sent via mail in written form.
2. Application Confirmation: After receiving the application, the Medical Service Management Department will verify the reasons for the application and the completeness of the submitted materials. Subsequently, the department will notify the applicant via telephone, fax, or email to confirm the application, request additional materials, or inform them of a rejection based on the verification results.
3. Expert Review: The Medical Service Management Department will assemble experts in pharmacy, clinical trial, and medical reimbursement management to review whether the drug should be included in the NRDL. The review will yield clear opinions. It's worth noting that a second review of the same drug will not take place unless new significant evidence is presented.
4. Result Publication: Following the expert review results, the NHSA will issue an official notice and make corresponding adjustments to the NRDL. The determination results will also be communicated to the applicant via telephone, fax, or email.
The NHSA will conduct the determination process quarterly, reviewing eligible applications received in the previous quarter. Under special circumstances, the determination procedure may be carried out as needed. This initiative is expected to enhance the scientific and refined management of the NRDL and better fulfill the basic medication needs of insured individuals.
