山东出台新规！药企须加强“质量守门员”管理，对药品上市行使一票否决权

Core Points - The Shandong Provincial Drug Administration has revised the "Shandong Provincial Drug Quality Authorization Management Measures" to enhance drug safety from the source [1][2] - The revised measures emphasize the role of the "Drug Quality Authorizer," a senior management position responsible for the final approval of drug releases [1] - The new regulations aim to ensure that the quality authorizer has a strong professional background and practical experience, and is granted independence in their role [1][2] Summary by Sections - Regulatory Changes - The revised measures detail the responsibilities and qualifications required for the drug quality authorizer, who must be a full-time senior manager authorized by the company's legal representative [1] - The authorizer must provide a clear conclusion on the quality evaluation of each batch of drugs before they can be released [1] - Independence and Authority - The measures grant the authorizer full independence and review authority, ensuring that their work is not interfered with by other company personnel [1] - The authorizer has the right to access all information related to product quality, from raw material procurement to production processes and customer complaints [1] - Enforcement and Accountability - Strict regulatory measures are outlined for non-compliance, including warnings, interviews, and potential suspension of production and sales [2] - The new regulations elevate the internal responsibility for drug quality safety, holding key personnel legally accountable and compelling companies to fulfill their responsibilities [2]