新修订《药品生产监督管理办法》中风险管理的研究与探讨

目的：根据新修订《药品生产监督管理办法》实施要求,从风险管理角度对药品监管部门和药品上市许可持有人明确相关风险管理条款,细化具体内容和执行原则,并提出相应改进风险管理的思路。 方法：认真梳理《药品生产监督管理办法》关于“风险”的具体条款,结合具体案例分析研判风险管理。结果与结论：新修订《药品生产监督管理办法》对风险管理有了更明确的具体规定,坚持风险管理理念,是药品科学监管和保障药品质量的重要前提。

Research and Discussion on Risk Management in the Newly-revised Measures for the Supervision and Administration of Pharmaceutical Production

Objective: According to the implementation requirements of the newly-revised Measures for the Supervision and Administration of Pharmaceutical Production, relevant risk management items were clarified, specific contents and implementation principles were specified for both drug regulatory authorities and drug marketing authorization holders(MAH) from risk management perspective, and corresponding thoughts for improving risk management were put forward. Methods: Comb specific items about "risk" carefully in Measures for the Supervision and Administration of Pharmaceutical Production and analyze and judge risk management based on specific cases. Results and Conclusion: The new Measures for the Supervision and Administration of Pharmaceutical Production has more specific regulations on risk management. Adhering to the concept of risk management is an important prerequisite for scientific drug supervision and drug quality assurance.