深圳药企“上楼”遇阻①：“一企一策”VS规则透明

Core Viewpoint - The biopharmaceutical industry in Guangdong faces significant challenges in finding suitable production facilities due to stringent regulations requiring independent buildings for drug production licenses, which is particularly difficult in land-scarce cities like Shenzhen [2][3][4]. Group 1: Industry Challenges - Many biopharmaceutical companies in Shenzhen are struggling to find appropriate production sites, which hinders their ability to obtain production licenses and launch new products [2][4]. - The requirement for independent buildings for drug production licenses creates a bottleneck, as Shenzhen's land is extremely limited, making it hard to find standalone facilities [3][6]. - The lack of clear regulations and standards regarding the use of non-independent buildings for production further complicates the situation for biopharmaceutical companies [4][10]. Group 2: Regulatory Environment - The current regulatory framework in Guangdong follows a "one enterprise, one policy" approach, which lacks transparency and leads to uncertainty for companies seeking production licenses [10][11]. - The existing laws do not explicitly state that independent buildings are necessary for all types of drug production, yet practical enforcement makes it nearly impossible to obtain licenses without them [5][6]. - Recent discussions among industry representatives and government officials highlight the need for clearer guidelines and standards to facilitate the approval process for biopharmaceutical companies [12][13]. Group 3: Proposed Solutions - Suggestions have been made to relax the stringent requirements for independent buildings and to establish clear standards for multi-user production facilities [11][12]. - The establishment of a "white list" for drug categories that can be produced in multi-user facilities is proposed to enhance operational flexibility for biopharmaceutical companies [11]. - Industry stakeholders emphasize the importance of having transparent criteria for production site approvals to improve investment confidence and operational efficiency [12][14].