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 […]
What Are the Basic Qualifications Required for a Local Representative Enterprise of an Overseas Marketing Authorization Holder?
With the implementation of the national “drug marketing authorization holder” system, overseas Marketing Authorization Holders (MAH) must improve their establishment of local representatives in China. The National Medical Products Administration (NMPA) outlined the direction for these representatives in the “Interim Provisions on the Management of Local Representatives of Overseas Drug Marketing Authorization Holders (Draft for […]