There have been numerous new regulations put in place since China National Medical Products Administration (NMPA) joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017.
Among these regulations, pharmacovigilance has been a key area of focus. Notably, the Drug Administration Law (revised in 2019) was the first law to stipulate the implementation of a pharmacovigilance system in China. The law only outlines the system, and more detailed regulations came out afterward. On July 1, 2020, China’s Good Clinical Practice (GCP) went into force. On Dec. 1 of the following year, China’s Good Pharmacovigilance Practice (GVP) took effect.
The implementation of these new regulations poses significant challenges to industry stakeholders. Ensuring efficacy and compliance is of utmost importance. Digital pharmacovigilance solutions have emerged as a means of addressing these challenges. This webinar will introduce China’s PV regulations and digital solutions for PV.
1.1 China Drug Regulation Structure
1.2 History of China PV Regulation Development
1.3 China Drug Health Authorities
1.4 Main Regulations for Pre-marketing and PV Activities
1.5 Main Regulations for Post-marketing and PV Activities
2.1 eSAE: Digital Solution on Clinical Trial Safety Management
2.2 eSafety: Digital Solution on PV System Compliance Management
| Date | Time (GMT+8) | World Clock | Language |
| 2023-06-29 | 21:00 ~ 22:00 | London: 14:00-15:00 New York: 9:00-10:00 |
English |
Sr PV Director
Monica Xu has more than 10-year experience in pre-marketing and post-marketing PV at MNC. She has been working at Taimei Technology for over 7 years, focusing on providing digital PV solutions to local and global companies. She is DIA China Clinical Safety and Pharmacovigilance Working Group Leader.
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