Notice of the General Administration on Soliciting Opinions on relevant policies on encouraging innovation of pharmaceutical medical devices to implement full life cycle management of pharmaceutical medical devices (Draft) (2017 No. 54)

Source: CFDA 2017-05-12 In order to further deepen the reform of the review and approval system, promote the adjustment of the industrial structure and technological innovation of pharmaceutical and medical devices, improve the industrial competitiveness, and meet the clinical needs of the public, the State Food and drug administration, in consultation with the relevant departments of the State Council, drafted the relevant policies on encouraging the innovation of pharmaceutical and medical devices to implement the full life cycle management of pharmaceutical and medical devices (Draft for comments) Solicit opinions from the public It is suggested that the modification opinions be fed back to the State Food and Drug Administration (drug and cosmetic registration administration department) by email before May 25, 2017 The deadline for consultation is June 10 The amendment of laws and regulations in the draft shall be carried out according to relevant procedures Email: yhzcszhc@cfda.gov.cn is hereby announced Annex: relevant policies on encouraging innovation of medical devices to implement full life cycle management of medical devices (Draft for comments) annex of food and Drug Administration on May 11, 2017 on encouraging innovation of medical devices to implement full life cycle management of medical devices (Draft for comments) 1、 Implement the legal responsibilities of the listing license holders According to the decision of the Standing Committee of the National People's Congress in November 2015 on Authorizing the State Council to carry out pilot drug listing license holder system and relevant issues in some places, the production enterprises (hereinafter referred to as the listing license holders) with drug approval number registered in ten provinces (cities) of Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan ）It is required to bear all legal responsibilities for preclinical research, clinical trials, processing and manufacturing, quality of raw and auxiliary materials, distribution and distribution, clinical guidance of drug use and adverse reaction reports The listing license holder shall ensure that the clinical trial data of the drug listing application submitted is true, complete and traceable; ensure the quality of raw and auxiliary materials and packaging materials is reliable; ensure that the production process of the drug is consistent with the approved process and the production process is consistent and consistent; ensure that the quality of each batch of drugs sold is consistent with the sample submitted for approval; ensure that the drug has been used is reported to the regulatory authority in a timely manner Adverse drug reactions occurred in the process and improvement measures are proposed Professional companies and researchers entrusted by drug listing license holders to carry out research and development and clinical trials, manufacturing and processing enterprises and logistics distribution enterprises entrusted by the holders shall bear the responsibilities stipulated by laws and regulations and agreed in the agreement for the drugs approved for listing It is necessary to summarize the experience of pilot drug marketing license holders and, in combination with the revision of the drug administration law of the people's Republic of China, generally implement the system of marketing license holders among drug and medical device licensors (registrants) nationwide 2、 Improve the adverse reactions / events reporting system of medical devices Based on the existing ADR / event reporting system mainly by medical institutions, an ADR / event reporting system with listing license holders as the main body is established All listed license holders shall conduct continuous research on the listed medical devices, assess the risk situation, report the adverse reactions / events in the use process in a timely manner, assume the responsibility of adverse reactions / events report of the produced medical devices, and propose and improve the quality control measures according to the adverse reactions / events, and propose the application for modification of instructions and labels If the report is concealed or overdue, or if the medical institution reports or the patient reports but the listing permit holder fails to report, the regulatory department shall punish the listing Permit Holder severely The review organization shall organize the investigation and analysis of the adverse reactions / events reported by the enterprise, and order the enterprise to put forward the improvement measures and modify the specification and label application 3、 Carry out re evaluation of the injection on the market According to the relevant provisions of the drug administration law, it is necessary to reevaluate the safety, effectiveness and quality controllability of the approved injection according to the scientific progress of the injection drugs The production enterprise shall conduct comprehensive analysis on the research at the time of approval for listing and the follow-up research after listing, carry out product composition, mechanism of action and clinical trial research, and evaluate its safety, effectiveness and quality controllability We will strive to basically complete the re evaluation of the marketed injection in about 5 to 10 years Through re evaluation, we can enjoy the relevant policies of consistency evaluation of quality and efficacy of chemical generic oral solid preparations Continue to do a good job in the consistency evaluation of generic oral preparations 4、 Improve the re evaluation system of medical devices For the medical devices that have been registered and sold on the market, the holders of the registration documents shall make self-evaluation and improvement in a timely manner according to the scientific research and development, and take the initiative to re evaluate the problems and quality defects exposed by the adverse events, and put forward the rectification measures for the existing problems The above re evaluation results and rectification measures shall be reported to the original registration authority in a timely manner and implemented after being approved by the original registration authority If the re evaluation result shows that the registered medical device cannot guarantee safety and effectiveness, the holder of the registration document shall apply for cancellation of the medical device registration certificate In case of concealing the re evaluation results and failing to apply for cancellation due to cancellation, the original registration authority shall directly cancel the registration certificate and investigate and deal with the registrant according to law 5、 Seriously investigate and deal with the falsification of clinical trial data The signatories of the agreement between Party A and Party B of the clinical trial project and the researchers of the clinical trial project are the first persons responsible for the clinical trial data, and they shall bear all legal liabilities for the reliability of the clinical trial data If the drug and medical device evaluation and inspection institutions find that there are authenticity problems in the application materials, they shall promptly file a case for investigation As for the person in charge of the drug non clinical research or clinical trial research institution who falsifies or provides the serious false report, as well as the person in charge of the drug non clinical research or clinical trial report who falsifies or provides the false report, the registration applicant who swindles the approval certificate and produces or sells the drug medical devices, as well as the person in charge of the relevant contract research organization, relevant laws shall be investigated according to law Responsibility Those who refuse, evade or obstruct inspection shall be given a heavier punishment according to law If the applicant finds out and reports to the regulatory authority on his own initiative, he may be exempted from punishment 6、 Standardize the academic promotion behavior Medical representatives are responsible for the academic promotion of new drugs, introducing new drug knowledge to clinicians, and listening to the opinions in the clinical use of new drugs It is prohibited for medical representatives to undertake the task of drug sales, contact with doctors in private, and anyone in medical institutions to provide medical representatives, drug production and marketing and other enterprise personnel with the quantity of drug prescriptions issued by doctors themselves The academic promotion activities of medical representatives in medical institutions shall be carried out in public and filed in the designated departments of medical institutions If a medical representative misleads a doctor to use a drug or conceals an adverse drug reaction, he shall be investigated and dealt with seriously The holder of listing license (drug manufacturer) shall record the list of pharmaceutical representatives on the website designated by the food and drug regulatory department and make it public to the public In case of conducting drug trading activities in the name of drug representatives without being put on record and publicized, the relevant departments shall investigate and punish the relevant enterprises and drug representatives as illegal drug dealers 7、 Strengthen the capacity-building of review and inspection The evaluation of medical devices will be included in the scope of government purchasing services to provide standardized and efficient evaluation services for applicants Accelerate the informatization construction of review and approval, formulate technical requirements for electronic submission of registration of medical devices, improve electronic general technical document system, gradually realize electronic submission and review and approval of various registration applications, and improve the quality and efficiency of review and approval Establish the file of the listed drugs and medical devices 8、 Reform the drug clinical trial sample inspection system The technical research department of the applicant or the entrusted drug inspection agency shall issue the inspection report for the clinical trial samples, and submit the report together with the samples to the evaluation agency In the process of evaluation and verification, the applicant or the holder of the marketing license shall ensure that the clinical trial samples are consistent with the quality and efficacy of the application samples provided 9、 Implement the whole process inspection responsibility from R & D to use Establish a clinical trial project inspection mode based on risk and review needs, and strengthen on-site inspection and causal verification The national food and drug regulatory department shall organize the inspection of the R & D process of pharmaceutical medical devices and the implementation of the quality management specifications for non clinical research of drugs and the quality management specifications for clinical trials of drugs; the food and drug regulatory department at or above the provincial level shall be responsible for the inspection of the implementation of the production process and production quality management specifications for pharmaceutical medical devices; the business process and operation of pharmaceutical medical devices The municipal and county food and drug regulatory departments shall be responsible for the inspection of the implementation of quality management standards If the data is found to be untrue, incomplete or traceable during the inspection, risk control measures shall be taken in time and administrative punishment shall be given in accordance with the drug administration law of the people's Republic of China, the regulations on the supervision and administration of medical devices and relevant quality standards; if suspected of a crime, it shall be transferred to the public security organ for criminal responsibility All penalties shall be imposed on the responsible person The inspection and punishment results shall be disclosed to the public in time 10、 Build a team of professional inspectors Rely on existing resources to speed up the construction of inspector team, and form a professional inspector team with full-time inspector as the main body and part-time inspector as the supplement Each region shall establish a team of professional inspectors in line with the regulatory tasks within the existing institutions and framework to ensure that they can perform their regulatory responsibilities We will implement a graded management system for inspectors, strengthen the training of inspectors, strengthen the allocation of inspection equipment, and improve the inspection ability and level 11、 Strengthen international cooperation We will deepen policy and technical exchanges on drug and medical device supervision between multiple and bilateral sides, actively participate in the formulation and revision of international rules and standards, and gradually realize international sharing and mutual recognition of standards and results for review, inspection and inspection.