On March 17, the Liaoning Provincial Government announced the introduction of a new policy titled "Several Measures to Optimize the Business Environment and Promote High-Quality Development of the Pharmaceutical Industry." The measures are designed to invigorate innovation and support the sustainable, high-quality growth of the province's pharmaceutical sector.
The pharmaceutical industry in Liaoning is currently undergoing a critical phase of transformation. Compared with more developed regions, the province still faces challenges such as a relatively small industrial scale, significant gaps in output value, and insufficient innovation capacity. Companies are increasingly calling for lower institutional costs, faster review and approval processes, more transparent regulatory rules, and more targeted innovation support.
The new set of measures, consisting of 26 specific provisions, aims to integrate existing and newly introduced policies to enhance their forward-looking layout and precise implementation, thereby continuously injecting policy momentum into the innovation-driven development of the pharmaceutical industry.
The measures are organized around five key areas. Among the highlights is the nationwide pioneering implementation of an electronic accompanying goods document system for retail chain enterprises. Additionally, Liaoning has committed to setting processing timelines for export drug sales certificates, introduced the province's first list of medical devices eligible for expedited review and approval, and formulated detailed implementation rules for the quality management of radioactive drug operations—all of which are considered leading initiatives nationally.
To strengthen innovation in research and development, Liaoning has put forward six measures. These include amplifying the effects of pilot demonstration projects, deepening reforms in the review and verification service system, strengthening the standardized construction of medical device innovation service stations, increasing support for key products, enhancing drug R&D information services, and establishing communication platforms for medical device innovation. Specific actions involve improving the "early involvement, one-enterprise-one-policy" service mechanism, creating a more attractive and competitive institutional environment, setting up dedicated columns for drug R&D innovation services to facilitate the transformation of scientific achievements, and advancing technical support for drug review and inspection.
In terms of administrative efficiency, Liaoning proposed seven measures to deepen the "one-stop online service" reform, shorten review and approval timelines, establish priority review mechanisms for drugs and medical devices, optimize medical device registration and cosmetic filing management, simplify procedures for changes in drug production sites, support segmented drug production, and coordinate clinical trial support efforts. Key initiatives include promoting full online processing, optimizing procedures for non-sterile drugs of the same dosage form and non-therapeutic large-volume infusion production site changes, and combining license amendments, site changes, and GMP compliance inspections.
Furthermore, Liaoning introduced three measures focused on traditional Chinese medicine development, such as advancing the revision of TCM standards, promoting the transformation of TCM innovation research and hospital preparations into new drugs, and supporting the standardized cultivation and processing of Chinese medicinal materials. To enhance the industrial system, seven measures were outlined, including promoting digital and intelligent transformation in the pharmaceutical industry, developing modern drug logistics, encouraging integrated development of wholesale and retail, supporting drug chain operations, innovating radioactive drug management models, and facilitating the export and domestic registration of overseas-approved drugs and medical devices. Lastly, three measures aim to improve the development environment by fostering service-oriented law enforcement, optimizing supervision and inspection models, and cultivating a clean and upright atmosphere in drug regulation.