【Regulations】
 drug:
 Several drafts for comments were officially issued
 According to the information published on the CFDA website, in 2015, a total of 12 drafts were issued for consultation, some of which are expected to be officially promulgated in 2016.
 For the application projects that have been queued for many years, the CFDA's announcement on November 13, 2015 on soliciting opinions on "Opinions on Solving the Backlog of Drug Registration Applications and Implementing Priority Review and Approval (Draft for Comment)" (2015 No. 227) It is worth looking forward to.
 n this consultation draft, the scope of priority review and approval (including new drugs, drugs in urgent clinical need, and drugs with significantly improved quality), as well as the priority review and approval process, are clearly defined. Specific provisions are also made for the work requirements for review and approval and the time limit for each step.
 If the regulation is officially introduced in 2016, the slow review and approval speed that has plagued the industry for many years, resulting in a backlog that affects the launch of new products, may be alleviated. This is for drugs within the scope of priority review and approval. Good news. With the gradual improvement of the backlog, the queuing speed of other types of drugs will also be accelerated to a certain extent, which will be an important step for accelerating the launch of new products and the integration of international review.
 In addition, the CFDA's Announcement (No. 231, 2015) on soliciting opinions on the "Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Comment)", on soliciting the pilot scheme of the drug marketing authorization holder system and the registration of chemical drugs Announcements on the two consultation drafts for the classification reform work plan, and the announcement (2015 No. 221) on the management regulations for the filing of bioequivalence tests of chemical generic drugs (Draft for comments), etc. Widely concerned by the industry.
 For 2016, if these opinion drafts are released one after another, it will promote and accelerate the further development of new drug research and development in my country.
 Medical equipment:
 2 important new policies were officially introduced
 In terms of medical devices, 12 drafts for comments were also issued in 2015. Among them, the letter on soliciting opinions on matters related to the filing of medical device clinical trials (No. 25, 2015) issued on April 28, 2015 was published in July 2015. On the 7th, the official "Announcement on Matters Concerning the Recordation of Medical Device Clinical Trials" was issued.
 In 2016, there are many device regulations worth looking forward to. Among them, the "Quality Management Practice for Medical Device Clinical Trials (Draft for Review)" and the "Administrative Measures for the Accreditation of Medical Device Clinical Trial Institutions (Draft for Comment)" are directly related to clinical trials. ".
 1. The new version of GCP for medical equipment
 "Quality Management Practice for Clinical Trials of Medical Devices" is also often referred to as "GCP for medical devices". The specification has been widely concerned by all parties since it began to solicit opinions in 2012. However, after more than 3 years, by the end of 2015, there is still no official introduction. Most of the clinical trials of domestic medical devices are conducted with reference to ICH-GCP and drug GCP.
 Although CFDA once promulgated the "Regulations on Clinical Trials of Medical Devices (Order No. 5 of the Bureau)" on January 17, 2004, on the one hand, the regulations are relatively simple, only principles, and their guiding significance for trials is relatively weak; on the other hand, After more than 10 years of development, great progress has been made in all aspects of medical device testing. Various new experimental designs and technologies have been continuously adopted, and various new phenomena have appeared one after another. This version of the regulations can no longer meet the needs of practical work. This is why the industry pays great attention to GCP for medical devices.
 According to the continuous communication with the Medical Device Registration Management Department, the industry generally believes that if there is no accident, the medical device GCP should be officially introduced in 2016, and at the same time, the original regulations in 2004 will be abolished.
 Comparing the 2015 version of the "Quality Management Practice for Clinical Trials of Medical Devices (Draft for Review)" and the 2004 "Regulations on Clinical Trials of Medical Devices (Order No. 5 of the Bureau)", the changes between the two versions are quite large. The new version of GCP is much more operable in terms of specific implementation, and has made quite detailed regulations on the requirements for experimental medical devices, filing, test approval documents, multi-center clinical trials, etc.; Injury compensation, trial lead unit, sub-center ethics, etc. are also clearly defined in the new version of GCP.
 Therefore, medical device GCP is one of the expectations in 2016, hoping to bring a new atmosphere to medical device clinical trials.
 2. Qualification certification of medical device testing institutions
 On July 20, 2015, the "Administrative Measures for the Accreditation of Medical Device Clinical Trial Institutions (Draft for Comment)" was released. In the past, there was no independent clinical trial institution for medical devices. As long as it is a certified drug clinical trial institution, it can undertake the clinical trial of the device by default; however, considering that there are still differences between the device and the drug, the medical device will certify a batch of undertaking devices. testing institution. This is the background for the above-mentioned exposure draft.
 The accreditation of clinical trial institutions has always been the focus of attention of practitioners. In my country, a situation that has emerged in recent years is that there are many experiments and few institutions, and the supply is often in short supply. Therefore, how many institutions will the medical device certify this time? Does the list of medical device clinical trial institutions highly overlap with that of drug clinical trial institutions? It is a matter of concern to the industry.  
 It can be seen from the draft for comments that the certification of medical device clinical trial institutions is composed of qualification accreditation + regular review system, which can be divided into three situations: qualification accreditation, additional professional qualification accreditation and continuation of qualification accreditation. The provincial bureau is responsible for the initial review (document review + on-site inspection, 60 working days), and the CFDA and the Health and Family Planning Commission are responsible for the identification (spot check, 30 working days). If recognized, a medical device clinical trial qualification certificate will be issued, valid for 5 years.  
 Since the birth of clinical trial institutions, the suggestion to cancel institutional certification has not stopped. At present, there are many experiments and few institutions, and institutions are on the relatively strong side. Although the sponsor shoulders the responsibility of supervising and managing the project, in actual work, it is often unable to really supervise the work of the clinical trial institution; because the clinical trial institution undertakes multiple projects at the same time, the number of subjects and investigators often cannot meet the needs of the project. , which is one of the reasons for some of the problems in the experiment.
 Therefore, it is an unstoppable call for sponsors to decide on their own research centers like foreign countries, cancel institutional certification, provide more choices, and let the market determine the reputation of research centers and researchers. However, realistically speaking, it may be difficult to cancel the certification of clinical trial institutions in the short term, and a process is required.
 In 2016, the certification method for medical device testing institutions is expected to be introduced, which is a good start for medical device clinical trials.
 【Execution】
 From July 22, 2015, the clinical trial self-inspection and verification work, as of January 5, 2016, 1622 projects have been withdrawn through multiple rounds, and there are currently 444 projects left.
 On December 23, 2015, CFDA held a symposium on the verification of drug clinical trial data, and put forward suggestions and opinions on the problems found in the verification of drug clinical trial data and the next verification work. The meeting pointed out that clinical trial data fraud is a "cancer" in the development of the pharmaceutical industry, which seriously undermines the healthy development of pharmaceutical research and development, and seriously affects the transformation and upgrading of the pharmaceutical industry and social credibility. The verification revealed various problems in pharmaceutical R&D, reflecting the lack of responsibilities of enterprises, medical institutions, CROs and other parties, and it is necessary to reflect and draw lessons. The pain in the verification process is a necessary process for the rebirth of the pharmaceutical industry.
 Looking forward to 2016, what will the clinical trial look like after this inspection?
 Sponsor:
 Really take responsibility
 The sponsors who found problems in this inspection not only lost all their initial investment, but were not allowed to declare new products within the next three years. Those who were found to be fraudulent will also be investigated for legal responsibility, and the punishment is not too severe.
 In the past, some sponsors did not take clinical trials as a key step to verify the effectiveness of their products with an attitude of being responsible for the people's drug use, but regarded clinical trials as obstacles before the product was launched, and tried to avoid or bypass clinical trials. Or complete clinical trials at a lower cost and in a shorter time.
 From this perspective, sponsors often have the following problems: First, they do not pay enough attention to clinical trials and blindly reduce the cost and time of trials;
 In the "CFDA Notice on Further Strengthening the Self-Inspection and Verification of Drug Clinical Trial Data" (No. 266 of 2015) issued on December 17, 2015, it pointed out: "The applicant is the initiator and beneficiary of drug clinical trials, and is responsible for the registration of drug clinical trials. The declared data bears full legal responsibility."
 Therefore, after this verification work, the vast majority of sponsors have clarified their responsibilities, and the price paid for this is quite heavy. It is expected that from 2016, the sponsors can truly take on their own responsibilities and view clinical trials from a scientific and long-term perspective, not just short-term interests.
 CRO:
 Increasing fees become a trend
 After more than 10 years of development, a large number of contract research organizations (CROs) have emerged in China. The cost of CRO is mainly manpower, so the threshold for entering the industry is relatively low, and the competition in the entire market is also fierce.
 In recent years, the situation of pharmaceutical research and development has been relatively severe, with a high failure rate and great economic pressure. Under such circumstances, many large companies have cut research and development expenses. In order to take over the vicious competition of orders, individual CRO companies accommodated to the various requirements of the sponsors, and even signed an agreement of "guaranteed approval".
 In the process of project implementation, CRO must not only meet the various requirements of the sponsor, but also maintain the cooperation between researchers and research centers, and also control costs to improve profits. The failure of individual CROs to adhere to principles and bottom lines under pressure from several aspects is also one of the reasons for data quality issues.
 In this inspection, the above issues have been listed and announced, and the CRO companies involved have been announced, which will further promote industry self-discipline. In 2016, it is difficult for CROs to rely on low-price competition to estimate projects; raising fees has become a trend. But at the same time as the fee increases, it is also hoped that the service can be improved to ensure the progress and quality of clinical trials.
 Clinical trial institutions:
 Be more cautious in undertaking projects
 For a long time, clinical trial institutions and researchers have been complained more about the importance attached to the project, especially some principal investigators have only a small amount of time to spend on the trial and cannot guarantee the progress and quality of the research. Since the researcher is the generator of the test data, and the research center is the real source of the data, it is a fundamental solution to control the quality of the test from the data source.
 After this verification work, the general trend in 2016 is that, on the one hand, clinical trial institutions will more carefully select the trial projects to undertake; on the other hand, the next projects will be taken seriously to ensure the quality of the trials.
 This also puts forward higher requirements for the sponsor: before the start of the clinical trial, the sponsor must take it seriously, analyze it carefully, and provide enough information and data to support the necessity and feasibility of the clinical trial, in order to convince the clinical trial institution and the researcher to take over the project.
 Conclusion >>>
 2015 is a year of rapid changes, promoting rapid changes in the industry; 2016 will be a year of stable development, looking forward to turning changes and changes into driving forces, and implementing various measures to truly promote a healthy, transparent and orderly industry. develop.