By Jessie Zhu, Head, Drug Safety Team, Deltamed Co., Ltd.
China joining the International Council for Harmonisation (ICH) in 2017, and China’s subsequent announcement to follow relevant ICH guidelines such as E2, M1 and M4 in 2018, is continuing to change the conduct of pharmacovigilance in China. Most importantly, to help industry standardize its programs and practices, China’s agencies have issued several safety and pharmacovigilance regulations. Necessary and useful, these have also presented challenges to an industry striving for compliance.
- New risk management requirements to protect patient safety in clinical trials increase the importance of the Individual Case Safety Report (ICSR) and Drug Safety Update Report (DSUR).
- Although Risk Management Plans (RMPs) are relatively new in China, they are an essential component of the entire product lifecycle; as part of an overall risk management system and strategy, the RMP must be continuously monitored and updated.
- Legally bound to present a drug product’s benefit-risk profile accurately, product labeling is one of the most important risk minimization measures to ensure patient safety.
DIA China 2019 presented Safety and Pharmacovigilance sessions that covered multiple aspects of these regulatory changes and resulting industry needs, including the sharing of E2 guidelines (on ICH Day), pharmacovigilance methodologies in post-marketing drug surveillance, and using real world data in pharmacovigilance.