直击产品入市痛点 深圳合成生物产业立法10月起施行

Core Viewpoint - Shenzhen has officially passed the "Regulations on Promoting the Innovative Development of the Synthetic Biology Industry in the Shenzhen Special Economic Zone," which will take effect on October 1, 2025, aiming to address key issues in the synthetic biology sector, including long product review cycles and slow application promotion [1][4]. Group 1: Legislative Framework - The regulations consist of 32 articles and represent Shenzhen's first attempt at industry promotion legislation in a "small cut" format, focusing on top-level design, result transformation, product market entry acceleration, service optimization, and support reinforcement [1][4]. - The legislation aims to enhance the efficiency of product review and approval processes, particularly in the fields of "new food," cosmetics, and other synthetic biology applications [5][6]. Group 2: Industry Growth and Data - Approximately 40% of the newly established synthetic biology companies in China over the past three years are located in Shenzhen, with the city's biopharmaceutical manufacturing industry experiencing an annual compound growth rate of 11.3% from 2014 to 2023 [1][7]. - A McKinsey report predicts that the global bioeconomy could reach $2 trillion to $4 trillion in the next 10-20 years, with biological modification contributing significantly to this growth [7]. Group 3: Central-Local Collaboration - The regulations emphasize "central-local collaboration," particularly in the review and approval of new raw materials, by fostering new models for review institutions and technical agencies [5][6]. - Shenzhen will work with national and provincial departments to build cooperative platforms and cultivate qualified technical review institutions [5][6]. Group 4: Comprehensive Support Measures - The regulations outline a comprehensive support system for the synthetic biology industry, addressing aspects such as space, talent, funding, and customs facilitation [7][8]. - Specific measures include prioritizing land supply for synthetic biology enterprises, increasing financial support through government investment funds, and facilitating customs processes for special biological medical items [8][9].