On March 17, the Information Office of the Liaoning Provincial Government held a press conference to elaborate on the recently issued "Several Measures for Optimizing the Business Environment and Promoting High-Quality Development of the Pharmaceutical Industry." The document, comprising 26 specific measures, includes several pioneering initiatives at the national level. Among these are the implementation of an electronic accompanying goods document system for retail chain enterprises, a commitment to processing time limits for drug export sales certificates, the creation of Liaoning's first list of medical devices eligible for fast-track review and approval, and the introduction of detailed implementation rules for the quality management of radioactive drug distribution.
To strengthen innovation in research and development, the measures propose six actions. These focus on amplifying the effects of pilot demonstrations, deepening reforms in the review and inspection service system, enhancing the standardized construction of medical device innovation service stations, increasing support for key products, improving information services for drug R&D innovation, and establishing communication platforms for medical device innovation. Specific steps include refining the "early involvement, one-company-one-policy" service mechanism, setting up dedicated columns for drug R&D innovation services, and building platforms to support review and inspection services.
Aiming to improve the efficiency of the review and approval process, seven measures are outlined. These involve advancing the "one-stop online services" reform, shortening review and approval timelines, establishing priority review mechanisms for drugs and medical devices, optimizing medical device registration and cosmetic product filing management, simplifying procedures for changes in drug manufacturing sites, supporting segmented drug production, and coordinating clinical trial support work. Initiatives include promoting fully online processing and optimizing processes for site changes concerning non-sterile drugs of the same dosage form and non-therapeutic large-volume infusions.
For developing distinctive characteristics in traditional Chinese medicine, three measures are proposed. These include continuously advancing the formulation and 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. Efforts will concentrate on key varieties with outstanding clinical value, utilizing early involvement and integrated research-review approaches, and facilitating the conversion of hospital TCM preparations into new drugs.
To promote transformation within the industrial system, seven measures target advancing the digital and intelligent transformation of the pharmaceutical industry, developing modern drug logistics, fostering integrated development of wholesale and retail, encouraging and guiding chain drug operations, innovating management models for radioactive drugs, supporting the export of drugs and medical devices, and assisting in the domestic registration and production of products already marketed overseas. This includes promoting deep integration of new-generation information technologies with the pharmaceutical supply chain.
Finally, to build a supportive development environment, three measures focus on creating service-oriented law enforcement agencies, optimizing supervision and inspection models, and fostering a clean and upright atmosphere within drug regulatory fields. Practices such as targeted legal education, promoting no penalty for first-time minor violations, establishing a "tolerance + credit repair" mechanism, deepening combined and comprehensive inspection models, and implementing inclusive and prudent supervision for new technologies and business models will be adopted. The provincial drug regulatory authority will intensify promotion, provide precise training, and ensure rigorous implementation of these measures to enhance the innovative vitality of Liaoning's pharmaceutical industry.