Sichuan issued a document to encourage innovation in pharmacy | Five major goals worth attention

Dec. 25 hearing December 21, Sichuan Province on "to deepen the reform of examination and approval system to encourage the innovation of medical devices, the implementation of the views" (hereinafter referred to as "opinions") for public comment, deadline to January 2018 10 days.

The Opinion proposes to expand the scope of clinical trials, complete the evaluation of consistency of generic drugs, re-evaluate injection, etc. In conclusion, it is imperative to expand the scope of clinical trial institutions, both for R & D of new drugs and re-evaluation of listed drugs, Test agency needs.

In addition, the "Opinions" once again reiterated the medical representative filing system, requiring drug listing license holders to be on behalf of the list of pharmaceutical representatives in the provincial Food and Drug Administration designated site for medical representatives is responsible for drug academic promotion, is strictly prohibited academic promotion, the line The reality of drug sales, once verified, according to the illegal operation of drugs on premises.

1, 5 years to strive for expansion of clinical trial institutions to 50 or more, to meet the maximum requirements of clinical trials of medical devices;

2, for the country set up in Sichuan drug audit inspection sub-center;

3, and strive to 2018 by the end of the completion of the national essential medicines oral formulation and reference preparation quality consistency assessment, and with 5 to 10 years to complete the listed drug injection re-evaluation work;

4, and strive every year in our province more than 5 innovative medical devices approved by the state, innovation ability into the forefront of the country.

5, a substantial increase in industrial competitiveness, with 5 years to achieve the province's pharmaceutical industry exceeded 500 billion yuan scale.

Each city (state) people's government, the provincial government departments, the immediate agencies, the relevant units:

In order to conscientiously implement the "Opinions of the General Office of the State Council of the CPC Central Committee General Office on Deepening the Reform of the Examination and Approval System for Drugs and Drugs, Encourage Innovative Medical Devices" (Office Word [2017] No. 42), improve the examination and approval efficiency and service level of medical devices for medical devices and comprehensively The implementation of the responsibility of the whole life cycle of pharmaceutical medical devices, to promote innovation and development of pharmaceutical and medical device industries and deepen the supply-side structural reform, and effectively protect the people safe and effective use of medicines, now on our deepening reform of the examination and approval system to encourage drug medical Equipment innovation put forward the following implementation advice.

(A) The clinical trial agencies significantly expanded.Scientific establishment of efficient, true and reliable, more traceability of clinical trial evaluation and evaluation system to encourage clinical trials and clinical trials agencies to carry out clinical trials, with 5 years to expand the clinical trial agency to 50 Above, the maximum to meet the medical and clinical needs of medical devices.

(II) Effectively improve the examination and approval ability, earnestly implement the institutions, personnel and funds for the review and approval of pharmaceutical medical devices, and promote the review and examination of pharmaceutical medical devices and the construction of the infrastructure and capacity of the institutions; speed up the establishment of professional inspectors and simplify the examination Review and approval of the process, optimize the ecological innovation, and comprehensively improve the effectiveness of our province medical equipment review and approval, safety and quality control.For the country in Sichuan to establish a drug audit inspection sub-center.

(III) Significantly improve the quality of listed pharmaceutical products Accelerate the evaluation of the consistency of the quality and efficacy of generic drugs, fully implement the encouragement policy of evaluating the consistency of generic drug quality and efficacy, and strive to achieve the consistency of the quality of oral preparations with reference preparations of national essential drugs by the end of 2018 Sexual evaluation, and strive to 5 to 10 years to complete the listed drug injection re-evaluation work.

(D) continue to enhance the ability of innovation of medical appliances. Give full play enterprise And take the leading role of innovation incubator such as Chengdu Tianfu International Bio-city to promote the R & D and innovation of medicine and medical devices in our province, exert the advantages of traditional Chinese medicine formulations in the development of new drug of traditional Chinese medicine and fully implement the system of drug listing holder And the holder's legal responsibility and strive every year in our province more than 5 innovative medical devices approved by the state, innovation ability into the forefront of the country.

(V) A substantial increase in the competitiveness of the industry The Company earnestly implemented the development concept of innovation, coordination, greenness, openness and sharing, proactively adapted itself to grasp the cutting-edge and high-end of the R & D of pharmaceutical and medical devices around the world and stimulated the innovation vitality of the pharmaceutical industry.

Reduce the institutional costs of pharmaceutical products from R & D to the listing and realize the rapid development of the pharmaceutical industry from a medium to high-end position and continuously meet the multi-level and diversified health needs of the people and the scale of the province's pharmaceutical industry in five years Break 500 billion yuan.

(F) Promote the reform of clinical trial management .Considering the responsibility of the principal investigators, the legal responsibilities of the sponsors and researchers, and the responsibility of supervising and inspecting clinical trials .Agencies with clinical trial conditions shall, after registering at the designated website of the food and drug regulatory department , Before accepting registration of the applicant commissioned to carry out clinical trials.

Encourage social forces to invest in the establishment of clinical trial institutions to support medical institutions, medical research institutions, and medical institutions of higher learning to carry out clinical trials, perfect the ethics committee mechanism, standardize the ethical review and improve the efficiency of ethics review.

Support the registration of the applicant to hire a third party to evaluate the clinical trial agency certification, to encourage medical institutions to establish full-time clinical trial departments, equipped with professional clinical trial researchers, establish clinical trial conditions and capabilities of the medical institutions level assessment, evaluation and evaluation system, improve Incentives for clinical trials to enhance clinical research capabilities.

(VII) Strengthen the supervision and inspection of clinical trials Establish and perfect the drug research and development platform and the drug clinical trial platform in line with the quality management standards of non-clinical research and the quality management standards of drug clinical trials.

Support the development of clinical trials to strengthen the clinical trials of drug clinical trials of bioequivalence pilot projects to strengthen the non-clinical research, clinical trials of on-site inspection and as a result of examination, the test results to the public.

A second class of medical devices undergoing clinical trials for the treatment of serious life-threatening and disease-free conditions of treatment may benefit from a preliminary observation, ethically-mandated, and subject to informed consent, within the framework of a clinical trial For other patients, their safety data can be used to register an application.

Assist applicants to carry out clinical trial simultaneously in China on the approved overseas unlisted new drugs.The data of the second type of clinical trial of medical devices obtained from overseas multinational centers that meet the relevant requirements for the registration of medical devices in China are applicable to the provincial food and drug products Registrar registration application.

Encourage clinical trial institutions in our province to participate in international multicenter clinical trials, severely punish the fraud of clinical trial data, and ensure that the research materials and data submitted are true, complete and traceable, and investigate the legal responsibilities of responsible persons according to law.

8. Encourage the innovation of medical equipment for medicine By adhering to the innovative development train of thought that combines self-creation with creation and imitation, the special examination and approval system for innovative medicines should be implemented and a provincial drug trial data protection system should be established; , Accelerate the deepening reform of medical and health system.

Encourage pharmaceutical and medical equipment enterprises to increase investment in research and development, and strengthen research and development of new products and continuing research of products already on the market. Encourage pharmaceutical and medical equipment enterprises to introduce high-level research and development personnel and establish a high-quality R & D team.

Guided by clinical values, we encourage the use of modern science and technology to research and develop traditional Chinese medicine (traditional Chinese medicine), encourage the development of traditional Chinese medicine based on the advantages of traditional dosage forms, and strengthen the quality control of traditional Chinese medicine. hospital Preparation of quality standards and secondary research and development.

Support the clinical application of new drugs Encourage and support medical devices such as biomedical materials, nuclear technology medical equipment, medical imaging equipment, medical testing equipment, cancer treatment equipment, wisdom diagnosis and treatment equipment, TCM diagnosis and treatment equipment, bio-3D printing and high- R & D.

(IX) Accelerate the review and approval of innovative drugstores Establish a review and approval system supported by review, inspection and inspection, implement the examination and approval system for the related review and approval of pharmaceutical preparations, APIs, pharmaceutical excipients and packaging materials Adapt to the production regulatory system, establish and improve in line with the characteristics of traditional Chinese medicine after the listing management system and technology evaluation system.

Strengthen the clinical trial of early and mid-term indicators of the efficacy and predictability of the clinical value of the drug product guidance, and urge enterprises to develop risk management and control programs, according to the requirements of research.

The establishment of innovative medical devices special review and approval channels, the national science and technology major projects and national key research and development programs and other support as well as by the National Clinical Research Center for clinical trials and approved by the central management department of the second category of innovative medical equipment, food and drug supervision Authority to give priority review and approval.

(X) do a good job of generic drug consistency assessment .Shortly implement the generic drug review and approval of the original research drug as a reference preparation requirements, urging the drug manufacturing enterprises in the province has approved the listing of generic drugs, in batches in accordance with the provisions of the method and Reference preparations for quality consistency assessment, submitted to the evaluation results.

Guide the development and production of generic drugs to encourage enterprises in the province to improve the standards and quality of generic drugs through technological progress and strictly abide by state regulations and refrain from further registration of generic drugs that fail to pass the quality consistency assessment within the prescribed time limit.

(11) To implement the principal responsibility of the holder To promote the full implementation of the system of the listed license holder, to strengthen the holder's legal responsibility for research and development, clinical trials, manufacturing, sales and distribution, and adverse drug reaction reports of medical devices The listing licensee directly reports the adverse reaction and adverse event system, timely reports the occurrence of adverse events, evaluates the risk situation and takes the initiative to carry out re-evaluation.

The re-evaluation finds that the product can not be guaranteed to be safe and effective, and the holder of the listing license should apply for the cancellation of the listing approval in time.Having any report of overstaying or overdue reporting, the Provincial Food and Drug Administration shall cancel the listing of the second type of medical device according to law license.

The holder of the drug listing license shall record the list of the pharmaceutical representatives on the website designated by the provincial food and drug regulatory authority. The pharmaceutical representatives shall be responsible for the academic promotion of the drug products. It is forbidden to sell drugs in the name of academic promotion. Once verified, .

(XII) Establishing archives of medical and medical equipment Provincial Food and Drug Administrations shall organize the pharmaceutical manufacturing enterprises in the province to truthfully fill in information on active ingredients, auxiliary materials, sources of raw and supplementary materials, production technology, production parameters and drug descriptions.

Overdue drug registration number not registered, to the public, to enter the drug delisting process.According to the restrictions announced by the relevant state ministries and commissions to encourage approval of drug catalogs and the establishment of the national list of drugs listed in time to the community or the applicant Public medical equipment, medical equipment catalogs, registration and patent information, test data protection period and other information, and guide the imitators orderly application, scientific and rational development of research and development and reporting programs.

(13) To improve the quality control system for review and evaluation, to strengthen the examination and approval ability and information construction, to launch the speed-up plan for the registration inspection of innovative medicines and medical devices, and to set up a program focusing on clinical medicine (including Chinese medicine) professionals, pharmacy, Pharmacology and Toxicology, Chinese Pharmacology, Statistics and other professionals composed of drug review team, set up by the clinical medicine (including Chinese medicine), clinical diagnosis, mechanical, electronic, materials, biomedical engineering and other professionals in the medical device audit Comment team.

Improve electronic general technical documentation system, strengthen the risk assessment of quality and safety of pharmaceutical medical devices, strictly review and approve pharmaceutical injection, strengthen research on common problems in technical review, study and formulate technical evaluation standards, and reduce the discretion of evaluation.

In addition to technical secrets such as the production process, the conclusions and bases of the review are fully disclosed, the registration application is formulated and the technical requirements are submitted electronically, the electronic general technical documentation system is to be improved and electronic submission and review and approval of various types of registration applications are gradually implemented.

(14) To fully implement the responsibility of supervision and inspection.The Provincial Food and Drug Administration is responsible for establishing a real-time dynamic supervision and inspection system for the entire production process of pharmaceutical and medical devices, the quality control of pharmaceutical production and the implementation of quality management standards for medical devices, The food and drug regulatory department is responsible for establishing a real-time dynamic supervision and inspection system for the entire process of the operation of pharmaceutical medical devices, the quality management standard of pharmaceutical operations, and the implementation of quality management practices of medical device operations. Implementation of a real-time dynamic supervision and inspection system with good source prevention, stringent process control and strict risk control.

Strengthen the flight inspection efforts, increase the number of testing batches and inspection frequency .Check the problems found in accordance with the law promptly investigated and dealt with, take timely risk control measures, the transfer of suspected criminal prosecution criminal responsibility .To establish a 'blacklist' system, improve ' Exposure Taiwan 'mechanism, the effective use of quality announcement of the role of a sword to openly check and punish the public the results of illegal and illegal behavior of people and behavior nowhere to hide.

(15) Implementing the duty of confidentiality of staff members, conscientiously enforcing the Confidentiality Law and confidentiality provisions, and participating drug Medical device acceptance examination, review and approval, inspection and inspection and other supervision staff, the confidentiality of the technical secrets and experimental data submitted by the applicant for registration .In violation of the confidentiality provisions, according to the law to investigate the responsibility, the results to the public, suspected Criminal, the transfer of justice to pursue criminal responsibility.

(16) Strengthen the Organizational Leadership The provincial departments and departments should fully recognize the necessity of deepening the examination and approval system for drug reform to reform the innovation of pharmaceutical medical devices, insist on applying the rule of law and the rule of law, attaching great importance to deepening the reform and encouraging innovative work, And support it as an important part of building an innovative nation and building a beautiful, prosperous and harmonious Sichuan.

Provincial Food and Drug Administration should be with the provincial government, provincial Development and Reform Commission, Provincial Economic and Information Technology Commission, Science and Technology Department, Department of Finance, Human Resources and Social Security Department, Provincial Health and Family Planning Commission, Provincial Intellectual Property Office, the province medicine Bureau and other departments, give full play to Sichuan Province drugs medical instruments Review the role of the review and approval system in reforming the joint conference system and promptly study and resolve the contradictions and problems encountered in deepening the reform and encouraging innovation.

Departments should perform their duties according to law and work together to form a joint force for reform and innovation, earnestly implement the tasks and effectively handle every line of defense from the laboratory to the hospital.

(XVII) Intensifying Collaborative Collaboration The Provincial Food and Drug Administration will play a leading role in implementing the reform and innovation in a concrete manner and in carrying out its tasks in a coordinated manner. The Provincial Development and Reform Commission should include the construction of clinical trial institutions in the construction and development of medical institutions, Increase investment in the construction of medical institutions.

Science and Technology Department should grasp the innovative drugs and innovative medical device research and development related scientific and technological research, for major new drug creation major projects funds, key research and development plans and other support. Provincial Economic and Information Technology Commission to strengthen medical innovation-driven transformation and development planning and guidance, and strengthen clinical medication Production and security. Department of Finance to do a good job review and approval of medical devices, inspection and inspection required funding protection.

Human Resources and Social Security Department to establish and improve the dynamic adjustment mechanism of medical insurance drug catalog, in time, in accordance with the provisions of the new drug into the province of basic medical insurance coverage.

Provincial Health and Family Planning Commission in a timely manner will be the province's new drug into the public hospital centralized drug procurement, to strengthen the guidance of clinical trial agencies, to strengthen clinical trial researchers ethics and professional knowledge training, to strengthen the combination of translational medicine and clinical medicine. Strengthen the protection of intellectual property of medical devices for medicines. Provincial Department of Traditional Chinese Medicine should do a good job in traditional Chinese medicine development and innovation.

(18) Enhancing team building Enhancing the strength of drug technical review, reforming the institutional employment system, recruiting talent for the society, implementing contract management, salary and social security, and implementing and implementing unit-based performance payroll incentives in accordance with the relevant state and provincial regulations Mechanisms: Establish a chief professional post system, set up a post system in a scientific manner, clarify responsibilities and tasks, work standards and terms of service, and employ personnel on posts.

Set up a public welfare-based, supplemented by provincial-level medical device review agency, is responsible for the province's second category of medical device review and quality control of medical device manufacturing implementation of the inspection, and strive to become the second category of national unified review of medical devices Evaluation agencies.

Through various employment and employment incentive mechanisms, the Company will actively promote the construction of a contingent of professional inspectors supplemented by full-time inspectors and part-time inspectors, so as to enhance inspection efficiency and inspection levels, and actively seek government procurement of services and entrustment Eligible social forces participate in the technical review of medical devices authorized by the state.

(XIX) Strengthen propaganda and interpretation.Considering the work of propaganda, deepen the publicity, deepen the reform, encourage the innovation of great significance, carry out training in stages and in batches for different objects, and strengthen the examination and approval system to reform important policies and major measures to be read, especially With the deepening of the review and approval system reform Encourage the innovation of medical equipment, staff, to focus on learning, training, grasping the spirit of the document, grasp the essence of the document.

We must promptly answer the hot issues of concern to all sectors of society, take the initiative to respond to social concerns and rationally guide all parties in their expectations and create a favorable atmosphere for public opinion to deepen the reform and encourage innovation.