FDA’s Office of Generic Drugs ReceivesApproval to Undergo Reorganization

FDA仿制药办公室获得重组批准20210108

Today the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization. The new structure, which will become effective at a later date in 2021, will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review while upholding FDA’s international reputation as the gold standard in the assessment and monitoring of generic drugs.  

 今天，美国FDA的药品评估与研究中心（CDER）宣布了仿制药办公室（OGD）重组的批准。新结构将于2021年晚些时候生效，它将加强OGD的运营，并使办公室能够满足不断发展的仿制药审查需求，同时保持FDA在仿制药评估和监测中作为黄金标准的国际声誉。

The guiding principles of the reorganization are to improve efficiency and consistency across OGD, and enhance collaboration and operational effectiveness. The reorganization will more effectively resource and support the high volume of generic drug applications FDA receives every year and will support the essential and intricate work of the generic drug program.

重组的指导原则是提高整个OGD的效率和一致性，并增强协作和运营效率。重组将更有效地利用资源和支持FDA每年收到的大量仿制药申请，并将支持仿制药物计划的复杂重要工作。

Changes include establishing a new Office of Safety and Clinical Evaluation. The new office will consist of the Division of Clinical Review and the Division of Pharmacology Toxicology Review, both being realigned from OGD’s Office of Bioequivalence; and the Division of Clinical Safety and Surveillance, being realigned from OGD’s Immediate Office.

变化包括建立新的安全和临床评估办公室。新办公室将包括由OGD的生物等效性办公室改组后的临床审查部门和药理毒理学审查部；以及OGD直属办公室改组的临床安全和监管部。

New divisions will be established in existing OGD Offices, including the Division of Bioequivalence Process Management (Office of Bioequivalence), the Division of Therapeutic PerformanceII (Office of Research and Standards), and the Division of Orange Book Publication and Regulatory Assessment (Office of Generic Drug Policy). Lastly, the Division of Quality Management Systems will move from the Office of Regulatory Operations to become the Quality Management Systems Staff within OGD’s Immediate Office.

现有的OGD办公室中将建立新的部门，包括生物等效性过程管理部门（生物等效性办公室），治疗表现II部（研究和标准办公室）以及橙皮书出版和注册审评部（仿制药政策办公室）。最后，质量管理系统部将从监管运营办公室转移到OGD直属办公室内成为质量管理系统职员。

Through the reorganization, OGD intends to continue its focus on ensuring a more efficient review process and create as tronger alignment of administrative, regulatory project management, program operations, policy, and drug development tool services. Modernizing OGD operations will help staff perform FDA’s mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities.

通过重组，OGD计划继续专注于确保更有效的审评流程，并在行政、注册项目管理、计划运营、政策和药物开发工具服务之间建立更紧密的联系。OGD运营的现代化将有助于员工在科学迅速发展，利益相关者期望不断变化以及新的法定权限和责任的环境中有效执行FDA的使命。

 The reorganization, along with new processes and policies, bolsters CDER’s mission to ensure that safe, effective, high-quality generic drugs are available for the American public.

重组以及新的流程和政策将支持CDER的使命，即确保向美国公众提供安全，有效，高质量的仿制药。