Hangzhou Will Start LDT Pilot in November

On October 15, the General Office of Hangzhou Municipal People's Government issued the "Notice on Several Measures to Accelerate the High-Quality Development of Biomedical Industry", which mentioned that it will actively support the pilot of Laboratory-Built Test (LDT) and conditionally allow LDT projects to serve for clinical promotion. The measures are effective from November 15, 2022 and will be valid until December 31, 2027.

For medical institutions qualified for drug clinical trials, the annual clinical trial services for Hangzhou enterprises to provide more than 5, 15, 30 projects, respectively, to the lead unit up to CNY 1 million, 2 million, 3 million of funding, respectively, to the participating units up to CNY 500,000, CNY 1 million, CNY 1.5 million of funding. Actively support the laboratory self-constructed assay (LDT) pilot, with conditions to allow LDT project services for clinical promotion.

The plan applies to enterprises and institutions, social groups, industry organizations, etc. that have registered according to law and are engaged in R&D, production, services and other production and operation activities in biomedical-related fields. The measures will focus on supporting research and development, production and services in the fields of pharmaceuticals, high-end medical devices, advanced pharmaceutical equipment, new service outsourcing, digital medical and medical beauty.

The Hangzhou Municipal Government has introduced 25 specific measures in four aspects: innovation and R&D capability, clinical research application, industrial cluster development, and ecological service system, covering funding, support, working mechanism, platform construction and other full support. It aims to accelerate the construction of biomedical innovation highlands, improve the industrial ecosystem, solidify high-quality industrial support, and create advanced manufacturing industry clusters, thereby accelerating the high-quality development of the local biomedical industry.