Recently, Shandong Province issued the "Implementation Opinions on Deepening the Examination and Approval System Reform to Encourage Innovation of Pharmaceutical and Medical Devices" (hereinafter referred to as the Opinions) to promote the transformation and upgrading of the pharmaceutical industry in the province and realize the transformation from large to strong.
The Opinions introduced 20 concrete measures in five parts including encouraging the innovation and development of the pharmaceutical industry, deepen the examination and approval system reform, strengthening life cycle management, enhancing technical support capacity, and improving safeguard measures. In optimizing the industrial structure, the Opinions proposed to encourage the merger and reorganization, joint development of pharmaceutical and medical device manufacturers, and gradually cultivate a group of large-scale enterprises with international competitiveness. Promote the combination of new products and new technologies with existing production capacity, and actively undertake the settlement of advanced pharmaceutical manufactures, innovative products, and overall relocation projects in Shandong province. Implement an international development strategy and introduce a number of international advanced technologies, innovative products and global outstanding enterprises. Support the development of processing and production enterprises, and create specialized entrusted processing bases. Give full play to the guiding role of the support funds for the pharmaceutical industry, and transform and upgrade the traditional pharmaceutical industry. Implement the construction of “High Quality Shandong Pharmaceuticals”, cultivate a number of branded products and well-known enterprises in the pharmaceutical industry to create the high-end pharmaceutical industry.
In encouraging product innovation, the Opinions clearly stipulates that Category 1 new drugs and improved new drugs with new drug certificates and industrialized in Shandong should be given post-subsidy funds, and the post-subsidy for major innovative products shall be increased. Category 1 new drugs that have been industrialized in Shandong Province shall be included in key research and development programs, and supported with a maximum post-subsidy of CNY 20 million. In addition, the Opinions also provide encouragement in industrial cluster development, promotion of transformation and upgrading of the circulation industry, and optimization of services.
According to Ma Yuenan, Director of Shandong Food and Drug Administration, the Shandong provincial government will soon establish a joint meeting system with the deputy governor as the general convener to coordinate the drug trial reform.