Core Viewpoint - Shenzhen's pharmaceutical companies are facing challenges with the "upstairs" industrial development model due to regulatory approval standards for production facilities, prompting discussions on how to better support these enterprises [1][5]. Regulatory Standards - The Guangdong Provincial Drug Administration clarified that having an independent factory is not a prerequisite for obtaining a drug production license, except for specific high-risk drugs that require dedicated facilities [2][4]. - Approval is based on the compliance of production management, pollution control, ventilation, and transportation conditions with national standards, rather than the independence of the facility [2][4]. Cost Considerations - Pharmaceutical companies weigh the costs of rent and "upstairs" renovations when deciding on their production locations, considering factors like potential interference with neighbors [3]. - The cost of "renovation" in non-independent facilities can be significantly higher due to the need for additional measures to ensure safety and compliance with regulations [3]. Support for "Upstairs" Enterprises - The regulatory body aims to treat "upstairs" enterprises fairly and will not lower standards for their production facilities compared to independent ones, ensuring compliance with national requirements [4][5]. - The administration is exploring ways to better serve companies that choose the "upstairs" model, focusing on professional guidance and support for innovative products [5].

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].