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 draft’s critical aspects and its implications for pharmaceutical companies operating in China. Scope of Application: The guideline applies to post-marketing safety evaluations conducted by marketing authorization holders (MAHs) to address identified safety issues, as mandated by relevant laws, regulations, or regulatory authorities. These evaluations, referred to as “causal evaluations,” aim to determine the causal relationship between the drug and safety concerns. Signal evaluation and risk
