In order to implement the requirements of establishing a pharmacovigilance system as regulated in Drug Administration Law of China, the National Medical Products Administration (NMPA) issued the “Good Pharmacovigilance Practice” (GVP) on May 13, 2021, which has become effective since December 1, 2021. As the first pharmacovigilance-related supporting document for the newly revised Drug Administration Law of China, it defines the work scope of MAHs and clinical trial sponsors.
The “Good Pharmacovigilance Practice” is of great significance to build a pharmacovigilance system, regulate pharmacovigilance activities in China. With a lot of experience introduced from ICH and other developed countries. GVP is much more comprehensive than the previous pharmacovigilance regulations, which mainly focused on ADRs. It provides official guidance for Chinese pharmaceutical companies on almost every step in pharmacovigilance activities. For some overseas companies, the release of the new GVP means that the old time when they paid not as much attention to pharmacovigilance in China as other markets should end. Instead, they need to comply with the new GVP requirements, especially those particular to China.
In this webinar, Mr. Daniel Yu, associate PV Director of Zhejiang Taimei Medical Technology Co., Ltd, will explain the background, scope of application, and framework of pharmacovigilance regulations in China.
Who Should Attend？
The responsible person, the person in charge of pharmacovigilance, pharmacovigilance personnel, quality management personnel, and personnel of related departments in pharmaceutical companies
Contract Research Organization (CRO) PV, MA, QA, QC, clinical staff