The National Healthcare Security Administration (NHSA) has released a letter titled “Letter on Requesting Assistance in Hearing Opinions on Volume-based Procurement (VBP) of Drugs Face to Face.” The NHSA will visit Shanghai to listen to the opinions and suggestions of relevant committee members and experts on VBP policy and the quality assurance of winning bids. This initiative involves health, industrial informatization, and medical products administration departments and focuses on collecting quality and efficacy clues supported by clinical data and statistically significant differences. It is a response to concerns about potential quality risks associated with certain VBP drugs raised by members of the Chinese People’s Political Consultative Conference and medical experts during the Two Sessions.
Communication Outline
The communication outline involves three main aspects:
- Introduction of Basic VBP Policies and Quality Assurance: This includes generic quality consistency evaluation (GQCE) work, hospital participation in research trials, inspection and sampling by medical products administration departments, real-world research on winning bids, and the disposal of certain winning bids with quality issues.
- Verification of Clinical Effectiveness: The NHSA will thoroughly verify the clinical effectiveness of VBP drugs and listen to the experiences of frontline clinical practitioners regarding their effectiveness. The focus will be on collecting cases where there are statistically significant differences in efficacy and safety indicators such as cure rate, treatment efficacy, and incidence of adverse reactions between winning generic drugs and originators. These cases will be summarized and submitted to the medical products administration department. Winning manufacturers will be urged to address the issue of delayed supply for some winning bids.
- Discussion on Ensuring Quality and Efficacy: The NHSA will discuss opinions and suggestions on further ensuring the quality and efficacy of VBP drugs. Winning manufacturers will be held accountable for any existing quality issues. Effective ways to ensure the quality and efficacy of VBP drugs will be explored, such as requesting the medical products administration department to strengthen consistency evaluation and subsequent daily inspections, publicizing the results of bioequivalence tests, and establishing feedback channels for medical institution efficacy comparison evidence.-Fineline Info & Tech
