A view of the Biomedical Enterprise Accelerator Phase 2 within the Shenzhen State Biological Industry Base in Pingshan District. File photo

Pingshan District has introduced a new service mechanism aimed at streamlining and accelerating companies’ applications in research and development (R&D), clinical trials, and market registration within the biopharmaceutical industry. This initiative establishes Pingshan as the first area in Shenzhen to implement a three-tiered drug and medical device approval service mechanism linking the municipal, district, and industrial park levels.

Under this mechanism, industrial park liaisons gather major enterprises’ challenges and requests related to product R&D, clinical trials, and registration submissions. Meanwhile, the market supervision and science and technology innovation departments provide expedited “green channels” for key projects to liaise with provincial and municipal authorities, facilitating faster project execution and quicker market entry.

Although recently formalized, this service mechanism has already been in operation. Pingshan selected six key biopharmaceutical industrial parks and 37 priority service projects for submission to the city’s market supervision administration for approval assistance. After the Shenzhen Biomedicine Innovation Industrial Park collected enterprise requests and submitted them to district industrial departments, two companies — Pregene and Ascentawits, both currently in the drug approval stage — have already benefited from the services and guidance.

“In the past, we had to schedule appointments with approval authorities weeks in advance and often waited a week for feedback on our drug and device R&D applications,” said a representative from Shenzhen Pregene Biopharma Co., Ltd. “Now, thanks to this three-tiered service mechanism, we receive feedback as soon as the next day.”

WYTD Medical Technology (Shenzhen) Co., Ltd., also located within the industrial park, noted that several of their products are undergoing clinical trial or registration. With the new service system in place, they can efficiently submit requests and receive timely responses from departments at every level.

Looking forward, Pingshan plans to leverage this mechanism alongside the provincial drug administration’s Pingshan branch of the medicine and device registration service station (currently under construction), to concentrate services on key industrial parks, enterprises, and projects.

By addressing specific company challenges, the district will deploy dedicated teams to provide coordinated assistance spanning project planning, site and equipment preparation, submission, and approval procedures — further enhancing the business environment within the Shenzhen State Biological Industry Base in Pingshan.