广东省药监局：药企“上楼”有先例，将继续探索做好为企服务

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].