药企“上楼”有先例 将探索做好服务

Core Viewpoint - The article discusses the challenges faced by Shenzhen's biopharmaceutical companies in obtaining production licenses when transitioning to multi-story industrial buildings, highlighting the regulatory standards and considerations involved in the approval process [5][6][9]. Approval Standards - The Guangdong Provincial Drug Administration clarified that having an independent factory is not a universal requirement for obtaining a drug production license, except for specific high-risk drugs that necessitate dedicated facilities [6]. - The approval process focuses on whether the production environment meets national standards, including management, pollution control, ventilation, and transportation conditions, rather than the independence of the factory [6][8]. Cost Considerations - Pharmaceutical companies weigh the costs of rent against the expenses associated with adapting to multi-story buildings, considering factors such as potential interference with neighbors and the associated renovation costs [7]. - The article notes that while independent buildings may have higher rent, the renovation costs for non-independent facilities can be significantly higher due to the need for enhanced safety measures [7]. Regulatory Approach - The Provincial Drug Administration aims to treat companies fairly, ensuring that those in multi-story buildings are held to the same standards as those in independent facilities, provided they meet the necessary regulatory requirements [8][9]. - The administration is open to exploring ways to better support companies that choose to transition to multi-story buildings while maintaining strict adherence to national standards [9].