Why is It Necessary to Conduct Due Diligence for Local Representatives in China?
Currently, an increasing number of domestic pharmaceutical sales companies are choosing to act as local representatives for overseas Marketing Authorization Holders (MAH) to expand their business scope. However, selecting a reliable local representative is not an easy task. Local representatives not only need to meet stringent regulatory requirements and fulfill their responsibilities and obligations, but […]
China Local Representative Duties in MAH System
Navigating China’s pharmaceutical market requires MAHs to ensure their local representatives meet strict regulatory standards. This article explores the key roles, qualifications, and responsibilities of local representatives under China’s MAH system. Learn why selecting and auditing your local representatives is crucial for compliance and understand their obligations under China Good Vigilance Practice (GVP) and pharmacovigilance […]
Understanding QPPV in China
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.
China PV Audits: Key Insights for Managing Local Representatives in China
In 2019, the Drug Administration Law in China fully implemented the Marketing Authorization Holder (MAH) system. In 2020, the China National Medical Products Administration (NMPA), the counterpart of the US FDA and EU EMA, issued the “Interim Provisions on the Management of Local Representatives of Overseas Drug Marketing Authorization Holders (Draft for Comments).” This article […]
Why Overseas MAHs Must Conduct China Pharmacovigilance Audits on Local Representatives
In the ever-evolving pharmaceutical landscape, rigorous safety measures are crucial. For overseas Marketing Authorization Holders (MAHs) with local representatives in China, one essential component of these safety measures is the China Pharmacovigilance audit. This process not only ensures compliance with Chinese regulations but also safeguards patient health by maintaining high standards of drug safety. Understanding […]
ICH E19 Guiding Principles Training Successfully Organised
On 24th October, ICH Guideline E19:Methods for Selective Collection of Safety Data in Specific Late Pre-market Clinical Trials or Post-market Clinical Trials, hosted by NMPA ICH Working Office, was successfully held. A total of more than 110 participants from domestic and foreign pharmaceutical companies, research institutes and representatives of drug regulatory agencies attended the event […]
China GVP Audit Guidelines and Requirements
On April 15, China’s National Medical Products Administration (NMPA) unveiled the Inspection Guideline for Pharmacovigilance, signaling a critical step in bolstering the oversight of pharmacovigilance activities. This comprehensive guideline underscores the pivotal role of provincial drug regulatory departments and places a significant onus on marketing authorization holders (MAH) to actively engage in and uphold pharmacovigilance […]
Implementation Path of the Pharmacovigilance System in China (3)
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 Synergis1c Governance among Diversified Pharmacovigilance Subjects Risk society is characterised by uncertainty and hazards, and the concept of consultative governance and risk sharing is more important in risk society to achieve the goal of balancing […]
Implementation Path of the Pharmacovigilance System in China (2)
2. 2 Challenges in Implementing Pharmacovigilance Systems 2. 2. 1 Single Route of Access to Data Monitoring The single access to ADR monitoring data in China has long been criticised, and medical institutions are the main source of ADR reports in China, accounting for more than 80% of the total number of reports (Table 2). […]
Pharmacovigilance in China
