fda建立与申请人沟通的会议轨制的经验对我国新药审批的.docVIP

摘要 新药的开发和审批是一个系统而复杂的科学过程。在此过程中，申办者和审评人员对新药的安全性、有效性和质量等特性和审批要求的了解程度和方式以及角度是不同的，这会导致新药研究开发进展缓慢、风险增大、审批结果不可预测及审批时间延长等诸多问题。因此，建立有效的双方沟通交流渠道是必要而且重要的。 FDA从1997年实施的PDUFA II开始积极探索在新药研究开发和审批过程中建立与申办者和/或申请人沟通交流的正式会议制度，并从法律和法规层面对正式会议制度进行了规范。FDA在其指南文件中对正式会议的类型、请求、评估、会议资料的要求和提交、召开会议的程序、会议纪要的整理等均作了详细规定。申办者可以在IND提交前、I期试验结束、IIa期试验结束、II期试验结束、NDA/BLA提交前等新药开发的关键环节申请正式会议。调查数据表明，这些会议对提高新药开发的质量和上市申请的质量是非常关键的。会议制度化加快了新药的开发，有效地缩短了新药审批时间，节约了开发成本，同时也减少了无效浪费。 国家食品药品监督管理局已建立了多种对申请人的咨询沟通途径，但现有的沟通渠道还存在一定的局限性和问题，还未形成对新药开发和审批的有效促进作用。在中国近期内实行SFDA(CDE)与申请人沟通会议制度化是非常必要的，而且是可行的。 关键词： 新药开发和审批； 正式会议； FDA 沟通交流会议制度； 国家食品药品监督管理局； FDA’s Experience in Establishing Meeting System for Communication With Sponsors or Applicants and Its Illumination on Chinese New Drug Review and Approval System Abstract Development and review of a new drug is a systemic, complicated, and science-based process. The sponsors and reviewers comprehend the new drug’s characteristics related to its safety, efficacy and quality, and technical requirements for approval with different approaches, viewpoints and degree during this process. These differences may lead to many problems such as slow progress of new drug development, enlarged risks, unpredictable review results and prolonged review process, etc. Therefore, it is necessary and important to establish the efficient communication channel between sponsors/applicants and reviewers. With the implementation of PDUFA II in 1997, FDA explored to establish the formal meeting system to communicate with the sponsors during development and review process of a new drug, and regulated it with law and regulations. FDA prescribes the types of meetings, procedures for requesting meetings, content of information packages, procedures for the conduct of meetings, and documentation in details in the Guidance. The sponsors can apply for the formal meeting at critical milestones in drug development, such as pre-IND, end of phase 1, end of phase 2a, end of phase 2, pre- BLA or NDA, etc. Su