State Council on the reform of the drug review and approval system for medical devices

In recent years, the rapid development of China's pharmaceutical industry, pharmaceutical and medical device quality standards continue to improve, to better meet the needs of public administration. At the same time, drug review and approval of medical devices in the problems have become increasingly prominent, registration data quality is not high, the review process requiring multiple complements, seriously affecting the efficiency review and approval;

generics duplication, multiple applications, vicious market competition, there is some quality of generic drugs is a big gap with the international advanced level; urgent clinical needs long time for approval to market new drugs, drug research and development institutions and researchers can not apply for drug registration, the impact of pharmaceutical innovation initiative.

For this reason, now make the following observations on the reform of the drug review and approval system of medical devices:

First, the main objective
(1) improve the quality of review and approval. Establish a more scientific and efficient review and approval system Drugs and Medical Devices, make approved the listing of the efficacy, safety, quality of Drugs and Medical Devices of controllability at or near the international advanced level.
(2) to resolve the backlog of applications for registration. Strict control of oversupply approval of the drug. Fight before the end of 2016 the backlog of inventory digestion completely realize the number of annual review of the application for registration and out of balance as soon as possible in 2018 to achieve the set deadline for approval.
(3) improve the quality of generic drugs. Speed ​​up generic quality conformance evaluation, and strive to be completed before the end of 2018 the National Essential Drugs oral formulation and the reference formulation quality than conformance assessment.
(4) to encourage research and development of new medicines. Encourage clinical value-oriented drug innovation, optimization and innovation drug evaluation and approval procedures for clinical needed to speed up the review of innovative drugs. Drug marketing authorization holders to carry out the pilot system.
(5) improve the transparency of review and approval. Full disclosure Drugs and Medical Devices registration acceptance, technical review, product testing and field inspection conditions and relevant technical requirements, public acceptance and approval of the relevant information to guide the orderly development and application the applicant.

Second, the main task
(6) increase the drug approval standards. The drugs into new drugs and generic drugs. The new drug from the current "in China was never marketed drugs" to "inside and outside China are not marketed drugs." According to the material basis of originality and novelty, the new drug into new medicines and improved medicines. The generics from the current "fake drugs has been the national standard" to "imitation of the original research and drug quality and efficacy of medicines is consistent." According to these principles, adjusting drug registration categories. Review and approval of generic drugs to the original research drugs as the reference formulation, newly approved to ensure consistent quality and efficacy of generic drugs and the original research. Drug application for registration before the reform is accepted, proceed in accordance with the original provisions of review and approval, and gradually solve the consistency problem with the original study drug quality and efficacy of consistency in the quality of the evaluation work; such companies to voluntarily apply consistent with the original study by the quality and efficacy of medicines The new standard for approval, you can set up the green channel, according to the new drug application for registration fees and costs, accelerate review and approval. These reforms after obtaining authorization in accordance with legal procedures, the pilot in chemicals.
(7) promote consistent quality generic drugs evaluated. Already approved the listing of generic drugs, according to research consistent with the original principles of drug quality and efficacy, quality consistency evaluation stages. Drug manufacturers should of their products in accordance with a prescribed method and reference preparation quality conformance assessment, submitted to the Food and Drug Administration of the evaluation results. Than the reference formulation after consultation with expert advice from the Food and Drug Administration of OK, you can select the original research drugs, you can also choose an internationally recognized same kinds of drugs. No reference preparation by the drug manufacturers conduct clinical efficacy trials. Within the prescribed period has not passed the quality conformance assessment of generic drugs, will not be re-registered; evaluation by quality consistency, allowing it to be marked in the instructions and labels, and support in the clinical application, bidding, Medicare reimbursement, etc. . Consistency in the quality of the evaluation work, the need to change the process has been approved, should the relevant provisions of the "Drug Registration" proposed supplementary application, Food and Drug Administration of the establishment of the green channel, to speed up the review and approval. Consistency in quality evaluation first before the 2007 revision of the "Drug Registration" generic drugs approved for marketing purposes. Drug labeling standard drafting company name in the national pharmacopoeia, encourage enterprises to improve the standard and quality of marketed drugs through technological progress. Improve the level of quality medicine, and actively promote the traditional Chinese medicine injection safety re-evaluation.
(8) to accelerate the review and approval of innovative drugs. Under special review and approval system for innovative drugs. Drug Evaluation accelerate approval of innovative drugs to combat AIDS, cancer, major infectious diseases, rare diseases and other diseases included in the national science and technology major projects and key national development plans, be transferred to the territory of the production of innovative drugs and child medication, and the use of advanced formulation technology, innovation treatment, have significant therapeutic advantages of innovative drugs. The urgent need to accelerate the clinical review and approval of new drugs, new drug application for registration of enterprises need in our commitment to its product sale price is not higher than the surrounding country of origin or country of comparable market prices.
(9) to carry the drug marketing authorization holder system pilot. Allow pharmaceutical R & D institutions and researchers to apply for registration of new drugs, when assigned to production, the company only site verification process and product testing, technical evaluation of drugs will not be repeated. Pilot after obtaining authorization to carry out in accordance with legal procedures.
(10) the main responsibility for the implementation of the applicant. Development of an application for registration in accordance with internationally accepted norms rules, applicants must be strictly in accordance with the conditions and the relevant technical requirements apply. It will now be handled by the provincial food and drug regulatory authorities, food regulators and Drug Administration review of the approval of an application for registration of drugs, adjusted for the Food and Drug Administration of the Internet on the admissibility. Conditions that do not comply with the relevant technical requirements of the application for registration by the Food and Drug Administration of a one-time inform the applicant of the need to add content. After entering the technical review process, in addition to new drugs and the first application for registration of fake medicines, will no longer require the applicant to supplement the information made only approve or disapprove of the decision.
(11) the timely release of the drug supply and demand and registration information. According to the national industrial structure adjustment direction, combined with market supply and demand, timely adjustment of the national drug industry policy, and strictly control the market oversupply, low-level repetitive production process behind the production and approval of generic drugs and encourage market development and production shortage of medicines, improve the availability of medicines. Food and Drug Administration regulation, together with the development and Reform Commission, Ministry of Science, Industry and Information Technology, Ministry of Health and Family Planning Commission developed and published periodically restricted and encouraged drug approval directory. Food and Drug Administration of the application information in a timely manner to the public registration of drugs, ordered the applicant to guide development and control low-level applications.
(12) improve pharmaceutical clinical trials for approval. Clinical trials carried out simultaneously in the territory to allow foreign unlisted after the approval of new drugs. Encourage domestic institutions involved in clinical trials of international multi-center clinical trial, test data can be used to meet the requirements of the application for registration. Clinical application of innovative drug trials, clinical value and subject focused review content protection. Strengthen the responsibility applicant, clinical trials agencies and ethics committees to protect the subject.
(13) seriously investigate the application for registration falsifications. Strengthen supervision of the whole process of clinical trials, clinical trial data to ensure true and reliable. The applicant, research institutions in the registration application, such as the presence of filing false research methods, quality standards, pharmacological and toxicological test data, clinical trial results, etc., the application shall not be approved for its Drug and Medical Device registration be revoked approved ; directly responsible be punished severely according to law, to issue false test results, related research institutions to cancel qualification test, the punishment results to the public.
(14) to simplify drug approval procedures, improve the drug re-registration system. Implementing drug medicinal packaging materials, pharmaceutical excipients associated with the approval of the medicinal packaging materials, pharmaceutical excipients alone at the time of approval of the drug for approval to apply for registration together review and approval. Simplified from the ancient classics side compound preparation of the approval. Drug simplify technology transfer program between drug manufacturers. The generic bioequivalence tests conducted by the approval to the record. For approval number (Import Drug License / Pharmaceutical Product License) unlisted within the validity period, you can not perform continuous study drug quality, efficacy and adverse reactions liability shall not be re-registered, the approval will be canceled after the expiration of the symbol.
(15) the reform of the way the medical device approval. Encourage the development of innovative medical devices, will have a core technology patents, is of great clinical value of innovative medical device registration, included in the scope of a special review and approval shall be given priority. Timely revision of medical device standards, improve medical device adoption rate of international standards to improve the quality of domestic medical products. By adjusting the product classification, the part of the mature, safe and controlled medical device registration and approval functions delegated by the Food and Drug Administration of the provincial food and drug supervision departments to.
(16) review and improve the quality control system. Referring to the development of internationally accepted rules of good quality management practices review. The formation of specialized technical review of the project team, specifically the trial and reviewers responsibilities, improve the collective review mechanism, strengthen the responsibility and time management. Establish a review committee of experts, to review the disputed findings from the review, to ensure that the results of scientific and fair review. Study on the Problems of the CPC to strengthen the technical review process, timely research results into technical standards guiding the review process, improve the review of the level of standardization, reducing review discretion.
(17) Drugs and Medical Devices comprehensive public review and approval information. Announced approval of a list of Drugs and Medical Devices and the legal basis for the social, approval requirements and processing time. Drugs and Medical Devices disclosed to the applicant for approval progress and results. Product marketing authorization at the time of ratification, synchronized technical review report published review, inspection, testing, etc., accept social supervision.

Third, safeguards
(18) to speed up the revision of laws and regulations. Sum Drug marketing authorization holder pilot system, drug registration classification reform progress, push to accelerate the revision of "Drug Administration Law of People's Republic of China." Combined with reform of administrative examination and approval system, pay close attention to the revised according to the procedure "People's Republic of China Regulations for the Implementation of the Drug Administration Law" and "Drug Registration" and so on.
(19) adjust pricing policy. Integration merge Drugs and Medical Devices registration, approval, registration fees. In accordance with the principle of balance of payments in general, improve drug medical device registration fees, adjusted once every five years. For small and micro enterprises to apply for Drugs and Medical Devices registration fees innovation given appropriate concessions. Fee income into the budget, and expenditure management. Requirements for review and approval by the budget for the work.
(20) to strengthen the review team. The reform of the personnel system and institutions, for the community to recruit personnel for the technical review, the implementation of contract management, their wages and social security in accordance with relevant state regulations. According to the review required, external experts involved in the technical review of relevant, clear their responsibilities and a duty of confidentiality and conflict of interest avoidance system. The establishment of professional chief post system, scientific setting reflects the technical review, inspection and other characteristics of the post system, clear responsibilities and tasks, work standards and working conditions, according to post employment in accordance with the implementation of the comprehensive ability and level of staff. Promoting Professionalism Drugs and Medical Devices inspector ranks. Improve the performance appraisal system, based on job responsibilities and job performance, adequate income gap opened to ensure the technical review, inspection personnel attracted into, stay. The Food and Drug Administration of government procurement of services as a pilot unit, commissioned by the government to buy services review mechanism meet the conditions, universities and research institutions involved in medical equipment and generic technical review, review of clinical trials, drug safety evaluation technical review.
(21) to strengthen the organization and leadership. Food and Drug Administration regulators should work together with the Central Office, Development and Reform Commission, Ministry of Science, Industry and Information Technology, Ministry of Finance, Human Resources and Social Security, Health and Family Planning Commission, the Medicines Agency, the General Logistics Department of Health and other departments, the establishment of drugs medical device review and approval system reform inter-ministerial joint conference system, strengthen coordination and guidance of reform work, study and solve conflicts and problems encountered in the reform, the region should strengthen the organization and leadership to reform, major promptly report the State Council.

State council
August 9, 2015