The official implementation of the China GVP is on December 1, 2021, emphasising the primary responsibilities of MAHs in Pharmacovigilance. Despite the existence of Level 3 Adverse Drug Reaction Monitoring Centres, a shortage of QPPVs has been observed in recent years in China.
In 2019, the Drug Administration Law in China fully implemented the Marketing Authorization Holder (MAH) system. In 2020, the China
In the ever-evolving pharmaceutical landscape, rigorous safety measures are crucial. For overseas Marketing Authorization Holders (MAHs) with local representatives in
On 24th October, ICH Guideline E19:Methods for Selective Collection of Safety Data in Specific Late Pre-market Clinical Trials or Post-market
On April 15, China’s National Medical Products Administration (NMPA) unveiled the Inspection Guideline for Pharmacovigilance, signaling a critical step in
Implementation Path of the Pharmacovigilance System in China (3) 3 Effec’ve Implementa’on Of China’s Pharmacovigilance System Path Recommenda’ons 3.1 Promote
2. 2 Challenges in Implementing Pharmacovigilance Systems 2. 2. 1 Single Route of Access to Data Monitoring The single access
Drug safety is the foundation for treating patients’ diseases and a crucial factor in ensuring that patients’ lives and health