China’s Draft Guidelines for Post-Marketing Drug Safety Evaluation: Open for Public Consultation
On September 24, 2024, the China National Medical Products Administration (NMPA) issued the draft “Guidelines for Post-Marketing Safety Evaluation of Drugs” for public consultation. These guidelines aim to strengthen post-marketing safety measures in alignment with Good Pharmacovigilance Practice (GVP) and international standards, ensuring the well-being of patients. This article provides a detailed overview of the […]
China NMPA Policy Interpretation on Direct ADR Reporting by Drug Marketing Authorization Holders
Background On September 30, 2018, China’s National Medical Products Administration (NMPA) issued the “Announcement on Direct Reporting of Adverse Drug Reactions by Marketing Authorization Holders”, outlining key requirements for Marketing Authorization Holders (MAHs) to take greater responsibility in monitoring, reporting, and managing adverse drug reactions (ADRs). This policy aims to elevate the pharmaceutical industry’s awareness […]
Q&A on China Good Pharmacovigilance Practice (GVP) – Official Version
Introduction As China strengthens its regulatory framework for drug safety, the implementation of the Good Pharmacovigilance Practice (GVP) guidelines plays a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. These guidelines, introduced by the National Medical Products Administration (NMPA), set clear requirements for Marketing Authorization Holders (MAH) and Sponsors […]
China GVP Audit Planning: Proven Strategies for Efficient and Successful Audits
Planning for Good Pharmacovigilance Practice (GVP) audits in China is critical for maintaining compliance and ensuring the safety and efficacy of pharmaceutical products. This article explores two essential levels of audit planning and provides practical insights for optimizing your GVP audits. Two Key Levels of China GVP Audit Planning: Prioritizing Key Areas: To maximize the […]
Master Remote GVP Audits in China
In today’s rapidly evolving regulatory environment, mastering the nuances of remote Good Pharmacovigilance Practice (GVP) audits is essential, especially when dealing with Chinese partners from the Marketing Authorization Holder (MAH) perspective. Whether you’re navigating online (remote) or offline (onsite) audits, ensuring compliance and mitigating risks are crucial for maintaining the integrity of your pharmacovigilance (PV) […]
QMS Audit: Adding Value in Pharmacovigilance (PV) Audits in China
What Do We Mean By “adding value”? We have heard so much about the importance of “adding value” during quality management systems (QMS) audits, but what does it really mean? Is it possible to add value without compromising the integrity of the audit or providing consultancy? In principle, all audits should add value, but this […]
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
As China strengthens its regulatory framework for drug safety, the implementation of the Good Pharmacovigilance Practice (GVP) guidelines plays a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. These guidelines, introduced by the National Medical Products Administration (NMPA), set clear requirements for Marketing Authorization Holders (MAH) and Sponsors in […]
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 […]