Effective monitoring programs have recently been developed. They use real world data to identify, assess, and control the risks of healthcare commodities.
Pharmacovigilance plays a vital role in real-world safety data.
Increasing the significance of the Individual Case Safety Report (ICSR) and the Drug Safety Update Report (DSUR) are new risk control standards to protect the safety of patients in clinical trials.
Although Risk Management Plans (RMPs) are relatively new in China, they are an essential component of the whole product life cycle; as they are part of the overall risk management framework and strategy.
Investigational New Drug (IND) application procedures and requirements must include providing RMP’s and pharmacovigilance system documents.
3 Key Points:
1.Data obtained on a drug during clinical trials was produced under strictly controlled clinical circumstances.
2.In September 2018, the CDE released its RMP requirements to be submitted as part of the New Drug Application (NDA) package.
3.With China now a member of ICH, labeling is one of the most critical risk minimization measures for patient safety in China.
“Market globalization will inevitably bring about regulatory globalization. This includes the conduct of safety monitoring and pharmacovigilance in China.” by Jessie Zhu, Head, Drug Safety Team of Deltamed Co., Ltd.
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