Preliminary results have been achieved in the pilot program of drug listing license holder system

Source: economic reference report 2017-11-24 The first pharmaceutical policy and industry innovation and development forum hosted by China Pharmaceutical News and Information Association and China Pharmaceutical city was held in Taizhou, Jiangsu Province, on November 24 The relevant person in charge of the State Food and Drug Administration introduced in the forum that since China officially launched the pilot of drug listing license holder system in June 2016, as of October 2017, 10 pilot provinces and cities have accepted the trial There are 560 applications for drug varieties, and the supervision object has changed from focusing on enterprises to focusing on products In November 2015, the Standing Committee of the National People's Congress authorized the State Council to carry out pilot drug listing license holder system in 10 provinces and cities including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan "The pilot work has achieved initial results." Yu Huan, director of the pharmaceutical registration department of the State Food and drug administration, said that the pilot work of the drug listing permit holder system has saved the cost of drug innovation, shortened the period of drug listing, increased the expected benefits of scientific research, reduced the repeated construction, optimized the allocation of resources and promoted the specialization of labor Moreover, the holder of the listing license is responsible for the whole chain of drug production and sales and the whole life cycle management of drugs, and bears all legal responsibilities for pre clinical research, clinical trials, production and manufacturing, distribution and distribution of drugs, adverse reactions monitoring, etc., which is more conducive to the implementation of the main responsibility But Chen Yongfa, a professor at China Pharmaceutical University, points out that in the current pilot work, the enthusiasm of researchers has not been sufficiently stimulated "Although scientific research institutions actively participate in the pilot, they still face challenges in terms of internal funds and management To become a holder, a scientific research institution not only needs a large amount of financial support, but also needs to form a management team throughout the life cycle and bear the corresponding risks " Chen Yongfa said that some holders do not have experience in drug production management and may lack the sense of responsibility and ability to guide and supervise the drug production process Moreover, due to the lack of sufficient communication between the holder and the entrusted party, the entrusted manufacturer may reduce the sense of responsibility for drug safety, increase the risk of violation, and lack the awareness of drug quality improvement In addition, the protection of intellectual property rights in commissioned production should also be paid attention to Chen Yongfa pointed out that the unclear division of intellectual property rights between the holder and the trustee is likely to lead to disputes over the ownership of intellectual property rights The entrusted party may use the intellectual property rights and trade secrets it holds from the entrusted project to engage in similar research and compete with the entrusting party for profits The lack of internal management ability of the entrusted party may lead to the disclosure of the intellectual property rights of the entrusting party Zhang Jixiang, President of China Pharmaceutical News and Information Association, said that in recent years, the State Food and drug administration has launched a series of new measures from the aspects of review and approval, ensuring drug quality and encouraging innovation In recent two years, CFDA has studied and issued 54 normative documents and 87 drafts for comments, further pushing drug regulation and industry development to a legal track with comprehensive norms, laws and regulations.