Another pound of medicine policy! To solve the pain point of clinical trials

On November 7th, the Shanghai Municipal Government website published the Implementation Opinions on Deepening the Reform of the Review and Approval System to Encourage The Innovation of Pharmaceutical Medical Devices (hereinafter referred to as the Opinions), referring to the two national strategies surrounding the construction of a free trade pilot zone in China (Shanghai) and a scientific and technological innovation center with global influence. The level, adhere to the demand-oriented, problem-oriented, effect-oriented, stimulate innovation and development vitality, promote the development of the world's leading biopharmaceutical industry cluster, promote the quality of pharmaceutical medical devices to reach the international advanced level, establish and improve the excellent global cities in the supply of pharmaceutical medical devices security system and after-the-fact supervision system.
fact, the Opinion is the specific landing of the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices issued by the General Office of the CPC Central Committee and the General Office of the State Council in October 2017, and consists of 32 reform tasks. Among them, in order to promote the important link in the process of drug research and development - clinical trials, Shanghai has made more clear provisions to reform the management of clinical trials, which is also the focus of drug review and approval system reform.
Not unique, two days ago, the official website of the National Drug Audit Center added the "clinical trial implied licensing publicity" column, China officially transferred the new drug clinical trials to implied licensing, that is, in China to declare drug clinical trials, from the date of application acceptance and payment of 60 days, the applicant did not receive the drug review center's negative or questioning opinions, according to the submitted plan to carry out drug clinical trials, reduce the time for enterprises to wait in line for clinical trial applications.
recent policies have supported the speed-up of reviews at the national regulatory level. Of course, with this, the pace of approval in the administrative sector has accelerated, and can standard-compliant clinical trial institutions withstand the current demand for BE trials in the evaluation of new drug development and generic consistency?shanghai clinical trial institutions to more than 80
for pharmaceutical research and development practitioners, the new drug research and development trials of clinical trials can be carried out on the success of its research and development. In the past, the shortage of clinical trial institutions has also hampered business development.
made it clear this time that Shanghai should give full play to the advantages of abundant medical resources and support the construction of research hospitals, Shanghai Translational Medicine Research Center and National Clinical Medical Research Center. Support registered applicants to hire a third party to evaluate and certify clinical trial institutions. We will promote the development of clinical trial institutions, promote the filing of clinical trial institutions, encourage social forces to invest in the establishment of clinical trial institutions, and strive to reach more than 80 clinical trial institutions in the city to achieve full coverage of clinical specialties.
, due to the development of generic drug consistency evaluation work, new drug research and development into a golden period, the number of clinical trial institutions available for work, has become the focus of industry discussion. Then, in October 2017, the two organizations jointly issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage The Innovation of Tablet Medical Devices, formally defined the qualification of clinical trial institutions for filing management, encouraged social forces to invest in the establishment of clinical trial institutions to participate in clinical trials, and resolved the bottleneck of insufficient clinical trial resources.
And the term was also drafted in 2017, the former CFDA said, disqualifies clinical trial institutions, medical institutions with clinical trial conditions in the regulatory designated website registration, can accept the applicant commissioned clinical trials. Encourage social capital to invest in the establishment of clinical trial institutions to provide clinical trial professional services. Clinical trial applicants may engage a third party to assess and certify the qualifications of the clinical trial institution.
the clinical trial institutions implement the record management, the regulatory authorities should strengthen the clinical trial project on-site inspection, the results of the inspection to the public. If a clinical trial project fails to pass the inspection, the data will not be accepted by regulators.
In July 2018, the State Drug Administration, on the basis of data review and on-site inspection, determined that 87 medical institutions, including the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine and the Fifth Central Hospital of Tianjin City, had qualified as drug clinical trial institutions and issued the Certificate of Qualification of Drug Clinical Trial Institutions. Data show that the total number of identified drug clinical trial institutions exceeds 700.
the implementation of the filing system, will greatly alleviate the situation of insufficient clinical trial resources, however, the specific practice of the operation of the rules, the filing system how to ensure the professional conduct of clinical trial institutions, and other issues, has not yet seen the official documents issued.multiple benefits to stimulate the enthusiasm of clinical researchers
" doctors are busy every day to see a doctor, job title, really put into clinical trials of the energy is simply not enough. "In a closed-door meeting, an industry insider made it clear the challenges that clinical trial agencies face in conducting clinical trials in a drug development environment.
how to improve the enthusiasm of the participants has become a lot of local confusion.
also explicitly mentioned this time, to support clinical trial institutions to carry out clinical trials. We will increase investment to support medical institutions, medical research institutions and medical institutions of higher learning to conduct clinical trials, to incorporate clinical trial conditions and capability evaluation into the evaluation of medical institutions' grades, and to incorporate relevant contents such as clinical trial quality management norms into the curricula of medical institutions of higher learning.
Opinion also proposes to establish a separate evaluation and evaluation system for medical institutions conducting clinical trials. Only for clinical trials of beds, not included in the total hospital beds of medical institutions, does not provide for bed efficiency, turnover rate, uity rate and other evaluation indicators. Medical institutions to carry out clinical trials, in accordance with the requirements of the establishment of independent, full-time clinical trial management departments, strengthen the clinical trial management departments standardized, standardized management, equipped with professional clinical trial researchers. Support foreign enterprises and scientific research institutions to carry out clinical trials of innovative pharmaceutical medical devices in Shanghai in accordance with the law, and promote the healthy development of clinical contract research organizations (CRO).
, we should further improve the innovation environment for medical personnel and encourage clinicians to carry out and participate in technological innovation activities of pharmaceutical medical devices based on practical experience. Under the policy framework of Shanghai's industry classification and regulation of the total amount of performance pay, improve the incentive mechanism of income distribution in medical institutions, guarantee the income level of clinical trial researchers, and consider clinical trials initiated by researchers as scientific research projects into the evaluation of scientific research performance. The establishment of incentive mechanism for clinical trial institutions and research teams, the conversion of scientific and technological achievements incentives, through public bidding for scientific research projects for personnel and other income, the introduction of high-level talents and teams, such as the required personnel funds, not included in the total unit performance pay. Clinical trial researchers and related personnel are treated equally with clinicians in terms of job promotion and title promotion, and the performance of clinical trials is regarded as an important part of job title evaluation. Multi-center clinical trials conducted as lead units can be regarded as provincial and ministerial issues.
It is obvious that Shanghai has made more detailed provisions on the basis of the State Office's Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices on the evaluation and evaluation system, the full-time management of clinical trials, the incentive mechanism for the participation of practitioners and the promotion of papers. to improve the efficiency of
, the efficiency of ethical review has previously been a problem for enterprises. This time, Shanghai mentioned that before a registered applicant can apply for a clinical trial, the clinical trial plan should be submitted to the ethics committee of the clinical trial institution for examination and approval. The National Clinical Medical Research Center and the clinical trial institutions that undertake major national science and technology projects and support projects under the National Key Research and Development Program should integrate resources, establish a unified ethical review platform, gradually promote mutual recognition of ethical review, and improve the efficiency of ethical review. Member units participating in multi-center clinical trials in Shanghai shall endorse the ethical findings of the clinical trial team leader's units and, in principle, not repeat the review. This will reduce communication and time costs for enterprises in pilot institutions. (Medical Economics)