药品再注册技术审评要点分析及思考

摘要

目的 继续完善再注册工作,更好地发挥其在药品监管中的作用 方法 对药品再注册工作的技术审评要点包括生产许可范围、质量标准、不良反应等进行归纳和分析.结果与结论 政策法规的进一步完善,“申报”、“审评”质量的提高,对再注册工作的更加完善有着重要意义.%Objective To improve the examining process of license renew application for supervision and management of drugs. Methods The main points of technological examination for drug license renew application were summarized and analyzed, including the range of production permit, quality standards, adverse reactions and so on. Results and Conclusion The improvement of quality of evaluation and policy and regulations play an important role in license renew application.