国家药品监督管理局：持续深化药品监管改革，助力药品研制创新

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the approval of the revised draft of the Drug Administration Law Implementation Regulations, emphasizing the need for strict enforcement, regulatory reform, and capacity building in drug supervision to ensure high-level drug safety and promote innovation in drug development [1][2]. Group 1: Drug Safety and Enforcement - Strict supervision and enforcement will be prioritized to ensure high-level drug safety, with a focus on the entire lifecycle quality management of drugs and increased efforts to combat illegal drug activities [1]. - The NMPA aims to enhance the quality of drug supervision by strengthening oversight in key areas and increasing enforcement actions against violations [1]. Group 2: Drug Innovation and Regulatory Reform - Continuous reform in drug regulation is essential to support drug research and innovation, with efforts to improve the efficiency of drug review and approval processes [1]. - The goal is to accelerate the market entry of new drugs that meet public demand, thereby enhancing the competitiveness of the pharmaceutical industry [1]. Group 3: Capacity Building and Regulatory Framework - There will be a focus on building a high-quality, professional regulatory workforce and innovating regulatory methods to improve overall regulatory effectiveness [1]. - The NMPA plans to develop a comprehensive and scientifically sound regulatory framework by revising supporting documents and technical guidelines in line with the new regulations [2]. Group 4: Training and Public Awareness - The NMPA will conduct extensive training and awareness programs to ensure effective implementation of the new regulations, targeting various regulatory levels and types of enterprises [1]. - The training will cover the background, reform measures, regulatory requirements, and legal responsibilities outlined in the new regulations [1].