The voice of the two sessions | improve the efficiency of administrative approval and enhance the competitiveness of China's pharmaceutical innovation

Source: joint proposal committee member of doctor's daily March 12, 2018: Qin Shukui, Ji Jiafu, Wang Shui, Wu Depei, Xu Congjian, Han Yaling, Chen Wei main contents: problems in the management of human genetic resources by the genetic Office of the Ministry of science and technology, delay the start of clinical trials of new drugs, waste resources, cause widespread controversy; after improvement, the problem has not been fundamentally solved The examination and approval process is complex, the steps and time limit are uncertain, the standards are not unified, and the opinions are not standardized; the new and old processes lead to confusion It has a significant impact on the development of clinical trials in China, the construction of pharmaceutical innovation ecosystem and the simultaneous research and development of new drugs on the market with the international community Suggestions: to change the examination and approval system into filing system or parallel examination; to simplify procedures and requirements; to formulate and publish examination and approval standards and standardize examination opinions; to develop supervision and service simultaneously and effectively improve examination and approval efficiency In 2015, the Ministry of science and Technology issued the notice on the implementation of the administrative license for the collection, collection, sale, export and exit of human genetic resources, stipulating that foreign pharmaceutical enterprises should carry out clinical trials, Or domestic pharmaceutical enterprises adopting units with foreign background (providing services such as sample collection, transportation, analysis, clinical supervision, data processing, etc.), shall apply to China Human Genetic Resources Management Office (CGO), and can be launched only after obtaining administrative approval Although it is of great significance for the effective protection and rational utilization of human genetic resources in China, the start-up of clinical trials of new drugs is delayed for 3-6 months, and the adjustment in the process of promotion is often delayed or interrupted, which obviously delays time and energy, wastes social and administrative resources, and causes fierce debate The Ministry of science and technology has organized discussions for many times, and issued the notice on optimizing the administrative approval process of human genetic resources in October 2017, which has been improved to some extent, but has not fundamentally solved the problem, and the actual situation is not optimistic Why does a regulation and improvement with good intention fail to achieve the expected good results? Main problems: complicated procedures, uncertain approval steps and time limit; 5 days for formal review and 5 days for acceptance of paper documents from the start of online application; at least 30 working days for the meeting to be completed within 20 days from the date of acceptance of paper documents; low approval rate for one time, repeated formal review and meeting, 2-3 times of the time; expansion of letter of commitment, all participating units must Signature and seal are particularly troublesome; approval standards are not unified and standardized, some rectification opinions are not clear, sometimes close to harsh, resulting in a maximum of 4 revisions; non major changes, such as sample size increase and decrease, need to be re declared; for the third-party laboratory, it needs to sign and seal repeatedly every time; the meeting time arrangement is not announced in advance, new and old processes will cause confusion in the declaration work; for the biological standard The examination and approval of records and materials are too strict; the guidance on how to distribute intellectual property is not clear, etc It is reported that the above situation has significantly affected the enthusiasm of foreign pharmaceutical enterprises to carry out clinical trials in China and the construction of local pharmaceutical innovation ecosystem, affected the simultaneous research and development and listing of new drugs with the international market, and hindered the scientific and technological innovation of medicine, especially the scientific exploration of new targets and mechanisms On February 28, 2018, the decision of the CPC Central Committee on deepening the reform of the party and state institutions proposed to "strengthen, optimize and transform the government's scientific and technological management and service functions" Therefore, we need to seriously consider: Why are all parties dissatisfied and what is the crux? Suggestion: change the examination and approval system to the record system or parallel examination: China has joined the ICH, Europe, the United States, Japan and other developed countries mostly adopt the record system for the management of human genetic resources in pharmaceutical research and development, weaken the prior examination and approval, strengthen the verification and supervision during and after the event, greatly reduce the workload, and implement high-efficiency and dynamic control It is suggested to actively learn the successful experience of CFDA review and approval reform, further simplify and optimize the matters, procedures and processes of approval; for those not involving specimen export, the filing system can be adopted to achieve international integration; if the filing system is temporarily not feasible, parallel review can be adopted Simplify the procedures and requirements: in accordance with the principle of "who benefits, who is responsible", cancel the letter of commitment, only require the sponsor (pharmaceutical enterprises or scientific and technological innovation institutions) to fill in the application for approval, and promise and assume the joint and several responsibilities of all parties involved in the collection, storage and R & D outsourcing of human genetic resources Clarify the approval standards and standardize the review opinions: refer to international practices, seek opinions from many parties, and formulate and publish the approval standards and specific requirements that are in line with the national conditions, scientific and operational as soon as possible, especially the sample size and application scope of tissues, blood, body fluids, etc.; the focus of the audit is on the flow direction and application of genetic data According to the principle of convenient declaration unit, the examination and approval opinions shall be given once to avoid differences each time For the application submitted for the second time, only the unqualified part of the previous time will be audited, and no review and meeting will be held The informed consent reviewed by the central ethics committee does not need to be reviewed repeatedly Announce the meeting time and arrangement in advance to facilitate the declaration unit to submit on time; cancel the old process and apply in accordance with the new process Supervision and service should be carried out at the same time, communication should be strengthened, and approval efficiency should be improved: the attitude of consultation window is good, but personnel change frequently, opinions are often inconsistent, it is suggested to formulate official questions and answers (FAQs), and update them in time In view of the problems in the previous examination and approval, summarize, analyze and summarize, take the initiative to train, guide and help relevant units, and appropriately improve the review cost to ensure the high quality of the application materials of the applicant Adapt to the change of government functions, actively listen to feedback and suggestions, increase reviewers and maintain stability, effectively and significantly improve the approval efficiency, and establish a regulatory system of human genetic resources with Chinese characteristics