On March 17, the Information Office of Liaoning Provincial People’s Government held a press conference to introduce the “Measures for Optimizing the Business Environment and Promoting the High-Quality Development of the Pharmaceutical Industry”.
This policy package includes 26 measures. Among them, the electronic accompanying document system for retail chain enterprises is the first of its kind in China. Measures such as committing to a time limit for processing export drug sales certificates, formulating Liaoning’s first list of medical devices eligible for expedited review and approval, and issuing detailed implementation rules for the quality management of radioactive drug distribution are at the forefront nationwide.
The package sets out six measures to leverage the demonstration effect of pilot programs, deepen the reform of the review and inspection service system, strengthen the standardization of medical device innovation service stations, step up support for key products, enhance information services for pharmaceutical research, development and innovation, and establish a communication platform for medical device research, development and innovation. It also introduces seven measures, including deepening the reform of one-stop online services, reducing review and approval time limits, establishing a priority review and approval mechanism for drugs and medical devices, improving the administration of medical device registration and cosmetics filing procedures, simplifying procedures for changes to drug manufacturing sites, supporting the segmented production of drugs, and coordinating support services for clinical trials.
The package proposes three measures to continue advancing the development and revision of standards for traditional Chinese medicine, promote innovative research in traditional Chinese medicine and the transformation of medical institution preparations into new drugs, and advance the standardized cultivation and processing of Chinese medicinal materials. It also sets out seven measures to promote the digital and intelligent transformation of the pharmaceutical industry, advance the development of modern pharmaceutical logistics, promote the integrated development of pharmaceutical wholesale and retail, encourage and guide the chain operation of pharmaceutical businesses, innovate the management model for radioactive drugs, support the export of drugs and medical devices, and support the registration and production in China of products already marketed overseas.
In addition, three further measures are proposed to develop service-oriented law enforcement authorities, optimize the supervision and inspection model, and consolidate a clean and upright atmosphere in the field of drug regulation.
