Previously, the review deadline for drug supplement applications required 200 working days, and for those involving on-site verification or supplementation, the time would be even longer. "On February 27th, Dong Lianpeng, the manager of the Comprehensive Administration Department of China Otsuka Pharmaceutical Co., Ltd., detailed the" time account "to a reporter from Science and Technology Daily." After the implementation of the new policy, the review deadline has been compressed to less than 60 working days, saving an overall of 5 to 8 months and enabling high-quality products to be launched faster. "Dong Lianpeng's new policy is the" Several Measures to Support the Innovative Development of Biopharmaceuticals in the Whole Chain of Tianjin City "(hereinafter referred to as the" Measures ") issued by the General Office of the Tianjin Municipal People's Government at the beginning of this year. This document contains 25 supporting measures, covering multiple aspects such as innovation sourcing, clinical research, registration approval, clinical application, industrial upgrading, and ecological optimization. Shortening the review deadline and accelerating product launch is an important area of new quality productivity. The development potential of the biopharmaceutical industry is enormous, but the processes of drug and device research and development, review and approval, and equipment use are complex, and policy coordination is urgently needed. We have introduced the 'Measures' this time to promote the creation of a biopharmaceutical industry full chain and full life cycle support service system covering' innovation policy source registration review clinical application market access ecological optimization ', and to solve the problem of insufficient policy coordination in the process of industry development Introduction by Zhu Yubing, Director of Tianjin Science and Technology Bureau. In order to ensure the precise implementation of policies, in May 2024, the Tianjin Science and Technology Bureau led the establishment of a special team for the development of the biopharmaceutical industry, conducting in-depth research and comprehensively sorting out industry pain points. Not long ago, the sterilization injection water replenishment application of China Otsuka Pharmaceutical Co., Ltd. was quickly approved, thanks to the relevant policies in the Measures, becoming one of the first varieties in the country to pass the pilot reform of optimizing the review and approval procedures. With policy support, the Tianjin Food and Drug Administration has provided early intervention guidance, pre-approval materials, and optimized processes to expedite the approval of our application Dong Lianpeng sighed and said that this not only accelerates the product launch, but also reduces the overall cost of the enterprise. After shortening the review cycle, enterprises have reduced idle resources and can invest more energy in research and development to enhance industry competitiveness. In addition, the research and development cycle of biopharmaceuticals is long and the investment is high. If the innovation return is not as expected, it will lead to a decrease in the enthusiasm of enterprises for innovation and research and development. To this end, the Measures innovatively propose the establishment of a "Catalogue of Key Research and Development of Innovative Products" and a "Catalogue of Guiding Application of Innovative Products". For products included in the R&D catalog, the science and technology department supports their preclinical research through municipal level science and technology plan projects, and the drug supervision and health departments provide full guidance to accelerate product launch, "said Mei Zhihong, Deputy Director of Tianjin Science and Technology Bureau. At present, Tianjin has made multiple breakthroughs in the field of biomedicine: the key breakthrough from "laboratory trials" to "engineering testing" of artificially synthesized starch using carbon dioxide; Application for market launch of a new indication for the treatment of lymphoma with Heyuan Biogen Ruida; The 2.0 version of the secondary development of major traditional Chinese medicine varieties such as Quick acting Heart saving Pills and Qishen Yiqi Dripping Pills has been launched. Strengthening departmental collaboration and jointly building an industrial ecosystem "Before the Spring Festival, we cooperated with the Tianjin Medical Products Administration to visit several hospitals that have the qualifications to apply for the" Radioactive Drug Use License (Class IV) "(hereinafter referred to as the" Class IV Certificate "), and provided training and guidance to relevant personnel. It is expected that the first Class IV Certificate in Tianjin will be issued in the first quarter," said Jia Qiang, Chairman of the Nuclear Medicine Branch of the Tianjin Medical Association, introducing the progress of related work. At present, radioactive drugs have been widely used in the diagnosis and treatment of tumors and neurological diseases, but their research and use have high barriers to entry, which restricts innovation and clinical applications. Jia Qiang said, "Hospitals have shortcomings in hardware standards, talent qualifications, and medical insurance policies, and urgently need policy support." Therefore, the "Measures" clearly propose to strengthen the construction of nuclear medicine disciplines and encourage tertiary hospitals to strive for the fourth type of certification qualifications. The Tianjin Science and Technology Bureau, in collaboration with the Municipal Education Commission and other departments, suggests that higher education institutions should explore measures such as offering nuclear medicine sub majors, joint talent training, and simulated evaluation and training on the basis of existing related majors, in order to promote the research and clinical application of radioactive drugs. Various departments in Tianjin are also actively giving the green light to the ecological construction of the biopharmaceutical industry. The Tianjin Municipal Health Commission promotes the transformation of scientific and technological achievements through activities such as "Innovative Transformation of Outpatient Services"; The National Medical Products Administration has issued four "fast track passes" for medical device products, reducing the review time from 120 working days to an average of 40 working days, providing full guidance for companies to launch their products; The Medical Insurance Bureau optimizes the management of medical service prices, establishes a "green channel" for evaluation, improves medical insurance payment methods, and provides additional compensation for innovative products. Tianjin will strengthen top-level design, promote the differentiated development of various districts, build specialized and distinctive biopharmaceutical industrial parks, and focus on new tracks such as radiopharmaceuticals, nucleic acid drugs, cell and gene therapy to accelerate the gathering of emerging industries Zhu Yubing stated. (New Society)