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The General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices

Article From:Xinhua News   Time:2017/11/1 9:58:46 【Size:B M SPrint
  Xinhua News Beijing October 8.Recently,the General Office of CPC Central Committee and the General Office of State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices,and issued a notice requiring all localities and departments to implement it conscientiously.


  The content of the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices is as follows.


  At present,China's pharmaceutical and medical equipment industry is developing rapidly;the innovation and entrepreneurship are in the ascendant;the reform of the review and approval system is under continuous advancement.However,as a whole,there is insufficient support for China's pharmaceutical and medical equipment innovation and there is a gap between the quality of listed products and the international advanced products.In order to promote the structural adjustment and technological innovation of pharmaceutical and medical equipment industry,improve industrial competitiveness and satisfy the public clinical needs,we put forward the following opinions regarding the further review and approval system reform and encouraging drug and medical device innovation.


  I.Reforming the management of clinical trials


  (1)Registration management is applied for accreditation of clinical trial institutions.After the institutions with clinical trial conditions can be registered on the designated website of the food and drug administration,such institutions can carry out clinical trial by accepting commission of the applicant for the registration of drugs and medical devices.The main researchers of the clinical subjects should have senior professional titles and should have participated in more than 3 clinical trials.The applicant for registration may employ a third party to evaluate and verify if the clinical trial institution has the qualification.The social private organizations are encouraged to invest in setting up clinical trial institutions.The regulations on the management of clinical trial institutions shall be formulated by the China Food and Drug Administration and the National Health and Family Planning Commission.


  (2)Support is provided for the clinical trial institutions and personnel to carry out clinical trials.The medical institutions,medical research institutions,medical colleges and universities are encouraged to carry out clinical trials.The clinical trial conditions and ability evaluation are included in medical institutions grade review.A separate evaluation system will be established for medical institutions that carry out clinical trials.The beds used for clinical trials are not included in the total beds of medical institutions.And there will be no evaluation indexes such as bed benefit,turnover rate,utilization rate and so on.The medical institutions are encouraged to set up full-time clinical trials departments and should be equipped with professional clinical trial researchers.The incentive mechanism of performance salary distribution should be improved to ensure the income level of the clinical trial researchers.The clinicians should be encouraged to participate in drug and medical device technology innovation activities.The clinical trial researchers should be treated equally with the clinicians in terms of job and title promotion.Foreign enterprises and scientific research institutions are allowed to carry out clinical trials of new drugs in accordance with the laws of China.


  (3)Perfecting the mechanism of ethics committee.The clinical trials should comply with ethical standards and should ensure that the subjects are informed of sufficient experimental information before voluntary participation and should sign the informed consent,to protect the safety,health and rights of the subjects.The clinical trial institutions should establish the ethical committee to review the clinical trial programs,review and supervise the clinical trial researchers'qualifications,supervise the development of clinical trials and undergo the review of the regulatory department.Each area may set up a regional ethics committee according to the needs to guide the ethics review work of the clinical trial institution,who may be authorized by the institutions or applicant with no ethical review conditions for the ethical review of clinical trial programs and for supervision of implementation of clinical trials.Health and family planning department,traditional Chinese medicine administration,food and drug administration and other departments should strengthen the management and guidance of the work of the ethics committee and business supervision.


  (4)Improving the efficiency of ethical review.Prior to the application of clinical trials by the registered applicant,the applicant should submit the clinical trial plan to the ethics committee of the clinical trial institution for approval.Where multi-center clinical trial is carried out in the country and after the ethical review of the clinical trial leader unit,other member units should recognize the conclusion of the group leader and should not repeat the review.The national clinical research center and the clinical trial institutions undertaking the major national science and technology projects and key national development plan projects,should integrate the resources to establish a unified ethical review platform and gradually promote the mutual recognition of ethical review.


  (5)Optimizing the approval procedure of clinical trials.The communication and exchange mechanism between registered applicants and review agencies should be established and improved.Before the acceptance of clinical trials and before the application of clinical trials of medical devices,the review agency should communicate with the registered applicant and make suggestions.If the food and drug administration does not give the negative response or doubt within a certain period after acceptance of the clinical trial application,the consent is deemed to be given and the registered applicant can carry out the clinical trial in accordance with the submitted program.Where changes in the clinical test plan,pharmacy or non-clinical research safety problems occur during the clinical trials,the applicant for registration shall timely submit such changes to the review institution;if any safety problems and other risks are found,the clinical trial program should be amended timely or the clinical trial should be suspended or terminated.The applicant of drug registration may issue or entrust the inspection institution to issue an inspection report for the clinical trial samples,and should submit the report and the samples to the drug evaluation institution,and should ensure that the samples used in the actual clinical trials are consistent with the submitted samples.The approval procedure of human genetic resources involving international cooperation in clinical trials should be optimized,and the process of clinical trials should be accelerated.


  (6)Receiving overseas clinical trial data.The clinical trial data obtained from multiple overseas centers that are in line with the relevant requirements of Chinese drug and medical device registration can be applied for registration in china.For drugs and medical devices applied for the marketing in China for the first time,the applicant should provide data on whether there is racial difference in clinical trials.


  (7)Supporting extended clinical trials.For the drugs and medical devices tested for the treatment of severe life-threatening diseases,if the effect can be obtained after preliminary observation and such drugs and medical devices meet the ethical requirements,they can be applied in the patients with their consent.The security data can be used to apply for registration.


  (8)Investigating the data fraud.The signatory of the clinical trial delegation agreement and clinical trial researcher is the first responsible person for clinical trial data,who should bear legal responsibility for the reliability of clinical trial data.The inspection model based on risk and review needs should be established,and the on-site inspection and cause examination on non clinical research and clinical trials should be strengthened.The inspection results should be made public.Where the samples fail to pass the examination,the relevant data will not be accepted.If there is false information,the heads of relevant non-clinical research institutions and clinical trials institutions and the person responsible for the report,the applicant and the person responsible for contract research organization will be investigated;the person who refuses,evades and hinder the inspection may be severely punished according to law.The registered applicant who finds out the problem initiatively and reports it in time may be punished as appropriate.


  II.Accelerating the review and approval


  (9)Accelerating the review and approval of clinical drugs and medical equipment for urgent need.For the drugs and medical devices for the severe life-threatening diseases with no effective treatment and for public health,if the effect can be obtained after early and mid-term indicators of clinical trials and the clinical value can be predicted,such drugs and medical devices can go on the market with conditional approval,and the enterprise should formulate the risk management plan,to carry out research as required.The research and development of new drugs and innovative medical devices is encouraged.The new drugs and innovative medical devices supported by national science and technology major projects and key national development plan with the clinical trials carried out by the National Center for Clinical Medicine and approved by the central management department should be reviewed and approved in advance.


  (10)Supporting the research and development of drugs and medical devices for rare diseases.National Health and Family Planning Commission or its agency(association)will publish rare diseases list and establish the registration system of rare diseases patients.The applicant for the registration of drugs and medical devices for rare diseases may ask for the exemption of application for clinical trials.For the drugs and medical devices for rare diseases that have been approved for sale abroad,they can be sold in China with conditional approval.The enterprise should formulate risk control plan and carry out research as required.


  (11)Strict review and approval of drug injection.The oral preparation converted to injection preparation should be strictly controlled.If the oral preparation can meet the clinical needs,the injection preparation should not be approved.The intramuscular injection converted to intravenous injection preparation should be strictly controlled.If the intramuscular injection preparation can meet the clinical needs,the intravenous injection preparation should not be approved.The application of changing dosage forms between large volume injection,small volume injection and sterile powder for injection without obvious clinical advantages should not be approved.


  (12)Carrying out the joint approval of the drugs and pharmaceutical raw materials and packaging materials.Pharmaceutical raw materials,pharmaceutical excipients and packaging materials should be reviewed and approved together with the approval of drugs registration application.No crude drug approval number will be issued.The approved raw materials,excipients and packaging materials and their quality standards will be announced in the specified platform for the related enterprises choosing.The drug license holder is responsible for the quality of the raw materials,excipients and packaging materials used in the preparation.


  (13)Supporting the inheritance and innovation of traditional Chinese medicine.The registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine should be established and developed.The relationship between maintaining the advantages of traditional Chinese medicine and the requirements of modern drug research and development.Innovative Chinese medicine should highlight the new features of the effect;modified traditional Chinese medicine should reflect the clinical advantage;TCM with classical prescription should be reviewed and approved in accordance with the simplified standard;natural medicine should be reviewed and approved in accordance with the modern medical standard.The clinical research ability of traditional Chinese medicine should be improved.The data for listing value and resource assessment are required for the registration application of Chinese medicine;the clinical value should be highlighted,and the sustainable use of resources should be promoted.It is encouraged to use modern science and technology to develop the traditional Chinese medicine and to give full play to the advantages of traditional Chinese medicine formulations for the development of new Chinese drugs.The quality control of traditional Chinese medicine should be strengthened.


  (14)Establishment of priority review and approval system for patent compulsory license drugs.In case of serious threat to public health,priority shall be given to the review and approval of the registration application of drugs for the implementation of compulsory license.The situation of serious threat to public health and the procedures for starting compulsory licensing shall be stipulated by the National Health and Family Planning Commission in conjunction with the relevant departments.


  III.Promoting drug innovation and generic drug development


  (15)Establishment of catalogue of drugs listed on the market.The drugs newly approved or passing the consistent evaluation of generics quality and efficacy should be listed in the catalogue of drugs listed on the market,indicating the innovative drugs,modified new drugs and generic drugs with the consistent quality and effect of the original drugs,as well as other information such as effective ingredients,dosage form,specification,license holder,the patent and test data protection period.


  (16)Exploring the establishment of drug patent linkage system.In order to protect the legitimate rights and interests of the patent holder,reduce the risk of generic drug patent infringement and encourage the development of generic drugs,the drug review and approval and drug patent linkage system should be established.When an applicant applies for drug registration,the applicant should indicate the involved patent and its ownership status,and notify the relevant pharmaceutical patent holder within the prescribed time limit.If there is any dispute over the patent right,the party concerned may file a lawsuit with the court,during which the technical review of the drug will not be suspended.For the drugs passing the technical review,the food and drug administration should make a decision if they are approved for marketing according to the court judgment,ruling or mediation;if the court judgment,ruling or mediation is not obtained over a certain period,the food and drug administration can give the approval.


  (17)Carrying out the pilot project of drug patent term compensation system.Some new drugs should be selected for trial,and appropriate patent period compensation should be granted for the delay of marketing due to clinical trials and review approval.


  (18)Improving and implementing the data protection system of drug testing.When applying for registration of drugs,the applicant may submit the test data protection application at the same time.A certain period of data protection should be given to the non-disclosure test data and other data acquired by the applicant for the innovative drugs,drugs for rare diseases,drugs for children,and innovative biological products.Data protection period shall commence from the date when the drug is approved for marketing.During the period of data protection,the other applicants are not allowed to apply for the marketing of the same type of products,except for the applicant acquiring the data by itself or the applicant getting permission of marketing.


  (19)Promoting the generic drug production.The innovation should be encouraged;the production of generic drugs should be promoted and the burden of drug use should be reduced.The list of patent expiration,termination,invalidness and no copy application should be regularly published;the generic drug research and development should be guided to improve accessibility of public medicines administration.The guidelines for related research and evaluation techniques should be improved;the imitation of biological medicine and the combination of drug and medical device with clinical value should be supported.The quality and efficacy consistency evaluation of generic drugs should be accelerated.


  (20)Giving play to the role of enterprises as the main body of innovation.The pharmaceutical and medical equipment enterprises should be encouraged to increase R&D investment;the new product research and development of listed products should be strengthened;the production process should be constantly improved.The scientific research institutions and researchers are allowed to apply for clinical trials on the premise of taking legal responsibility.Where the state funding is used to carry out the research and development of new drugs and innovative medical devices and related technology research and development which are taken as the transformation of scientific and technological achievements,the employer can specify or agree with the scientific research personnel on the means,amount and time limit of the reward and remuneration,so as to mobilize the enthusiasm of researchers and promote the transformation of scientific and technological achievements.


  (21)Supporting the clinical application of new drugs.The dynamic adjustment mechanism of medical insurance drug list should be improved;the medical insurance drug payment standard negotiation mechanism should be explored and established.The new drugs should be timely included into the payment range of basic medical insurance in accordance with the provisions;new drug research and development should be supported.The local departments can include the new drugs into the centralized purchasing scope of drugs in public hospitals according to the needs of disease prevention and control.The medical institutions are encouraged to purchase and use new drugs with clear curative effect and reasonable price.


  IV.Strengthening the whole life cycle management of pharmaceutical and medical devices


  (22)Promoting full implementation of the system of drugs marketing license holder.The pilot experience of drug listing permission holder system should be promptly summarized;the revision of drug administration law should be carried out and applied all over the country at an early date.The medical device R&D institutions and researchers are allowed to apply for medical device marketing license.


  (23)Implementing the legal liability of the marketing license holder.The drug marketing license holder shall assume full legal responsibility for the preclinical research,clinical trials,manufacturing,sales and distribution and adverse reaction reports of the drugs,and shall make sure that the research data and clinical trial data are true,complete and traceable;the production process shall be consistent with the approval process in compliance with the standards;each batch of drugs shall have the same quality with the sample;the ongoing research of the drugs shall be carried out.The adverse reactions shall be timely reported.Risk assessment shall be made and the improvement measures shall be taken.


  The medical devices marketing license holder shall assume full legal responsibility for the research and development,clinical trials,manufacturing,sales and distribution and adverse reaction reports of the medical devices,and shall make sure that the research data clinical trial data are true,complete and traceable;the ongoing research of the medical devices shall be carried out.The adverse reactions shall be timely reported.Risk assessment shall be made and the improvement measures shall be taken.


  The enterprises,institutions and individuals entrusted by the drugs and medical devices marketing license holder for research and development,clinical trials,manufacture,sale and distribution shall bear the responsibilities stipulated by laws and regulations and the agreement.


  (24)Establishing the system of direct reporting of adverse drug reactions and adverse events.Marketing license holder shall be responsible for adverse reactions and adverse events;otherwise the holder may be seriously punished in accordance with the law for no reporting or overdue reporting.The food and drug administration shall investigate and analyze the adverse reactions and adverse events and order the marketing license holder to suspend sales,recall the products and improve the quality control measures.


  (25)Carrying out the drug injection evaluation.According to the pharmaceutical science progress,the listed drug injection is reviewed,which may be finished in 5 to 10 years.The marketing license holder shall make comprehensive analysis of the study situation upon the marketing and continuous research after the marketing and carry out the research on product composition,mechanism and clinical efficacy and evaluate its security,effectiveness and quality control.The drugs and medical devices passing the evaluation will enjoy the related encouragement policies for consistency evaluation of the quality of generic drugs and the curative effect.


  (26)Improving the medical devices and equipment and evaluation system.The marketing license holder shall,according to scientific progress and adverse events evaluation results,actively carry out the evaluation on the marketed medical devices.If the products are found not safe and effective after re-evaluation,the marketing license holder should timely apply for cancellation of marketing license;if the related party hides the evaluation results and fails to apply for cancellation,the marketing license shall be cancelled and investigated according to law.


  (27)Regulating the behavior of drug promotion.The drugs marketing license holder shall register the medical representatives list on the website specified by the food and drug administration for the record and announce them to the public.A medical representative is responsible for drug promotion and shall introduce the drug knowledge to medical staff and listen to the suggestions and opinions of the clinical use.A medical representative shall carry out the academic promotion activities in public,which should be registered in the relevant department of the medical institutions.A medical representative is not allowed to undertake the task of drug sales.The quantity of drug prescriptions issued by the physician shall not be provided to the medical representative or the relevant enterprise staff.A medical representative who misleads the doctors using drugs or conceals adverse drug reactions shall be investigated;the person who carries out the drug business activities in the name of the medical representative shall be investigated according to the laws on illegal drugs business.


  V.Improving the technical support ability


  (28)Improving the system of technical evaluation.The technical evaluation system based on technical evaluation and supported by the inspection and examination should be established;the system of project manager review,the system of meeting communication between the evaluation mechanism and the registered applicant and the expert advisory committee system shall be improved.The internal management should be strengthened and the evaluation process should be standardized.A drug evaluation team shall be established to carry out new drugs evaluation;such team should consist of clinical medical professionals and professional personnel in pharmacy,pharmacology,toxicology and statistics.A medical device evaluation team shall be established to carry out the evaluation of medical devices and equipment;such team should consist of professional personnel in clinical medicine,clinical diagnosis,machinery,electronics,materials and biomedical engineering.In addition to the production process and other technical secret,the review conclusion and basis should be made known to the public and should be supervised by the society.The second-category medical device review standard should be unified,and the national unified review and evaluation should be gradually realized.


  (29)Carrying out the relevant work personnel's duty of confidentiality.The personnel who participate in drugs&medical devices review and evaluation,inspection and supervision work shall take a confidentiality obligation for the technical secret and test data submitted by the registered applicant.The person who is in breach of confidentiality obligations shall be investigated in accordance with the law and the processing results will be announced to the public;the criminal behavior shall be investigated by the judicial organs according to law.The management of the application for registration materials should be improved,to ensure the query and copy traceable.


  (30)Strengthening the construction of review inspection ability.The review of drugs and medical equipment should be included into the scope of services purchased by the government,to provide standard high-effect review services.The informationization construction of drug and medical devices evaluation and approval should be accelerated;the technical requirements of registration electronic submission should be developed;the electronic universal technical documentation system should be improved.The electronic submission and review&approval for all kinds of application for registration should be gradually realized.The archives on various types of marketed drugs and medical equipment should be established.