International Food & Drug Policy and Law Research Center, School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Institute of Regulatory Science, Tsinghua University, Biomedicine Hall, Rm C104, Beijing, 100084, China.
Invest New Drugs. 2021 Oct;39(5):1389-1398. doi: 10.1007/s10637-021-01117-2. Epub 2021 Apr 30.
China has been criticized for the long drug delay for a long time. There was little understanding of Chinese drug lag formation from the investigational new drug (IND) submission to the new drug application (NDA) approval. Therefore, we analyzed the problem of drug lag in China cumulating from the clinical trial starting lag to the lags formed during the regulatory process and discerned the key underlying factors. After investigating the availability in China of new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) between 1999 and 2019, we find that even though cutting regulatory process could reduce the approval lag, the clinical trial starting time in China is more important in drug lag reduction than shortening development time and review time. The reduction of the regulatory process also needs continuous efforts by defining the clinical value based on the medical needs, regulatory procedure harmonization, and intensive discussions between applicants and regulators during the drug development process. Meanwhile, proactive approaches should be taken to encourage developing the first generics in China. More importantly, enhancing domestic research and development capabilities is still the key to cutting the drug lag. Moreover, the China National Medical Product Administration (NMPA) should attach importance to the accumulation of regulation experience on innovative drugs and transform the style of regulating generics to new drugs.
中国长期以来一直受到药品审批延迟的批评。从新药临床试验申请（IND）提交到新药申请（NDA）批准，人们对中国药品滞后形成的原因知之甚少。因此，我们从临床试验启动延迟到监管过程中形成的延迟，分析了中国药品滞后的问题，并发现了关键的潜在因素。在调查了 1999 年至 2019 年间食品药品监督管理局（FDA）批准的新分子实体（NME）在中国的可及性后，我们发现，尽管缩短监管程序可以减少审批延迟，但在中国，减少药品滞后的关键在于缩短临床试验启动时间，而不是缩短开发时间和审评时间。减少监管程序也需要不断努力，通过基于医疗需求定义临床价值、监管程序协调以及在药物开发过程中申请人和监管机构之间的密集讨论来实现。同时，应采取积极措施鼓励在中国开发首仿药。更重要的是，提高国内研发能力仍是缩短药品滞后的关键。此外，国家药品监督管理局（NMPA）应重视创新药监管经验的积累，转变仿制药监管方式，向新药监管转变。
