Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices

In recent years, my country's pharmaceutical industry has developed rapidly, and the quality and standards of drugs and medical devices have been continuously improved, which has better met the public's drug needs. At the same time, the problems in the review and approval of drugs and medical devices have become increasingly prominent. The quality of registration application materials is not high, and the review process needs to be supplemented and improved many times, which seriously affects the efficiency of review and approval; generic drugs are repeatedly built and applied, and the market is viciously competitive. The quality of some generic drugs is far behind the international advanced level; the approval time for new drugs urgently needed in clinical practice is too long, and drug research and development institutions and scientific researchers cannot apply for drug registration, which affects the enthusiasm of drug innovation. To this end, the following opinions are put forward on the reform of the review and approval system for drugs and medical devices:

1. Main objectives

(I) Improve the quality of review and approval. Establish a more scientific and efficient review and approval system for drugs and medical devices, so that the effectiveness, safety, and quality controllability of approved drugs and medical devices reach or approach the international advanced level.

(II) Solve the backlog of registration applications. Strictly control the approval of drugs with oversupply in the market. We will strive to digest the backlog by the end of 2016, achieve the annual balance of registration applications and review numbers as soon as possible, and achieve approval within the prescribed time limit in 2018.

(III) Improve the quality of generic drugs. Accelerate the quality consistency evaluation of generic drugs, and strive to complete the quality consistency evaluation of oral preparations of national essential drugs and reference preparations by the end of 2018.

(IV) Encourage research and creation of new drugs. Encourage drug innovation guided by clinical value, optimize the review and approval procedures for innovative drugs, and speed up the review of innovative drugs urgently needed in clinical practice. Carry out a pilot program for the drug marketing authorization holder system.

(V) Improve the transparency of review and approval. Fully disclose the acceptance, technical review, product inspection and on-site inspection conditions and relevant technical requirements for drug and medical device registration, disclose relevant information on acceptance and approval, and guide applicants to develop and apply in an orderly manner.

II. Main tasks

(VI) Improve drug approval standards. Drugs will be divided into new drugs and generic drugs. New drugs will be adjusted from the current "drugs that have not been marketed in China" to "drugs that have not been marketed in China or abroad". According to the originality and novelty of the material basis, new drugs are divided into innovative drugs and improved new drugs. Generic drugs are adjusted from the current "drugs that imitate existing national standards" to "drugs that imitate the quality and efficacy of original research drugs". According to the above principles, adjust the drug registration classification. The review and approval of generic drugs should use the original research drugs as reference preparations to ensure that the quality and efficacy of newly approved generic drugs are consistent with the original research drugs. For drug registration applications accepted before the reform, continue to review and approve them in accordance with the original regulations, and gradually solve the problem of consistency with the quality and efficacy of original research drugs in the quality consistency evaluation work; if the enterprise voluntarily applies for approval according to the new standards consistent with the quality and efficacy of original research drugs, a green channel can be set up, and fees can be charged according to the new drug registration application fee standards to speed up the review and approval. The above reforms will be piloted in chemical drugs after obtaining authorization in accordance with legal procedures.

(VII) Promote the quality consistency evaluation of generic drugs. For generic drugs that have been approved for marketing, quality consistency evaluation shall be carried out in stages and batches according to the principle of consistency with the quality and efficacy of original research drugs. Drug manufacturers should conduct quality consistency evaluation of their products with reference preparations according to the prescribed methods, and submit the evaluation results to the CFDA. The reference preparation is determined by the CFDA after consulting experts. It can be an original research drug or an internationally recognized drug of the same kind. If there is no reference preparation, the drug manufacturer shall conduct clinical effectiveness trials. Generic drugs that fail to pass the quality consistency evaluation within the prescribed period will not be re-registered; those that pass the quality consistency evaluation are allowed to be marked on the instructions and labels, and support will be given in clinical application, bidding and procurement, and medical insurance reimbursement. In the quality consistency evaluation work, if the approved process needs to be changed, a supplementary application should be submitted in accordance with the relevant provisions of the "Drug Registration Management Measures", and the CFDA will set up a green channel to speed up the review and approval. The quality consistency evaluation work was first carried out on generic drugs approved for marketing before the implementation of the "Drug Registration Management Measures" revised in 2007. The name of the drug standard drafting company is marked in the national pharmacopoeia to encourage companies to improve the standards and quality of marketed drugs through technological progress. Improve the quality level of Chinese patent medicines and actively promote the safety re-evaluation of Chinese medicine injections.

(VIII) Accelerate the review and approval of innovative drugs. Implement a special review and approval system for innovative drugs. Accelerate the review and approval of innovative drugs for the prevention and treatment of diseases such as AIDS, malignant tumors, major infectious diseases, and rare diseases, drugs included in major national science and technology projects and national key research and development plans, innovative drugs and children's medicines transferred to domestic production, and innovative drugs that use advanced formulation technology, innovative treatment methods, and have obvious therapeutic advantages. Accelerate the review and approval of new drugs urgently needed in clinical practice. Enterprises applying for registration of new drugs must promise that the price of their products sold in my country will not be higher than the comparable market price in the country of origin or my country's surrounding areas.

(IX) Carry out a pilot program for the drug marketing authorization holder system. Allow drug research and development institutions and scientific researchers to apply for registration of new drugs. When transferring to enterprises for production, only on-site process verification and product inspection of the production enterprise will be carried out, and drug technical review will no longer be repeated. The pilot work will be carried out after obtaining authorization in accordance with legal procedures.

(X) Implement the main responsibilities of applicants. Formulate registration application specifications in accordance with international general rules, and applicants must apply in strict accordance with the prescribed conditions and relevant technical requirements. The drug registration applications currently accepted by provincial food and drug regulatory departments and reviewed and approved by the CFDA will be adjusted to be accepted online by the CFDA. For registration applications that do not meet the prescribed conditions and relevant technical requirements, the CFDA will inform the applicant of the content that needs to be supplemented at one time. After entering the technical review procedure, except for new drug and first generic drug registration applications, in principle, no additional information will be required for the applicant, and only a decision of approval or disapproval will be made.

(XI) Timely release of drug supply and demand and registration application information. According to the direction of national industrial structure adjustment and in combination with market supply and demand, timely adjust the national drug industry policy, strictly control the production and approval of generic drugs with oversupply, low-level duplication, and backward production technology, encourage the research and development and production of drugs in short supply in the market, and improve the accessibility of drugs. The CFDA will work with the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, and the National Health and Family Planning Commission to formulate and regularly publish the approval catalogues of restricted and encouraged drugs. The CFDA will promptly disclose drug registration application information to the public to guide applicants to orderly research and control low-level applications.

(XII) Improve drug clinical trial approval. Allow new drugs that have not been approved overseas to conduct clinical trials in China simultaneously after approval. Encourage domestic clinical trial institutions to participate in international multi-center clinical trials, and test data that meet the requirements can be used in registration applications. For applications for clinical trials of innovative drugs, focus on reviewing clinical value and subject protection. Strengthen the responsibility of applicants, clinical trial institutions and ethics committees to protect subjects.

(XIII) Seriously investigate and punish fraudulent registration applications. Strengthen supervision of the entire clinical trial process to ensure that clinical trial data are authentic and reliable. If applicants or research institutions submit false development methods, quality standards, pharmacological and toxicological test data, clinical trial results, etc. in their registration applications, their drug and medical device registration applications will not be approved, and those that have been approved will be revoked; the direct responsible persons will be severely punished in accordance with the law, and the research institutions that issue false test results will be disqualified from relevant tests, and the punishment results will be announced to the public.

(XIV) Simplify the drug approval procedures and improve the drug re-registration system. Implement the joint approval of drugs and pharmaceutical packaging materials and pharmaceutical excipients, and change the separate approval of pharmaceutical packaging materials and pharmaceutical excipients to the review and approval of them together when approving drug registration applications. Simplify the approval of compound preparations derived from ancient classic prescriptions. Simplify the drug technology transfer procedures between drug manufacturers. Change the bioequivalence test of generic drugs from approval to filing. If the approval number (imported drug registration certificate/medical product registration certificate) is not put on the market within the validity period and fails to fulfill the responsibility of continuously inspecting the quality, efficacy and adverse reactions of the drug, it will not be re-registered, and the approval number will be cancelled after expiration.

(XV) Reform the approval method of medical devices. Encourage medical device research and development innovation, and include the registration application of innovative medical devices with product core technology invention patents and significant clinical value in the scope of special review and approval, and give priority to it. Timely revise medical device standards, increase the adoption rate of international standards for medical devices, and improve the quality of domestic medical device products. By adjusting product classification, the registration and approval responsibilities of some mature, safe and controllable medical devices will be delegated from the State Food and Drug Administration to provincial food and drug regulatory departments.

(XVI) Improve the review quality control system. Formulate good review quality management standards with reference to international general rules. Establish a professional technical review project team, clarify the rights and responsibilities of the chief reviewer and reviewers, improve the collective review mechanism, and strengthen responsibility and time limit management. Establish a review expert committee to review controversial review conclusions to ensure that the review results are scientific and fair. Strengthen the research on common difficult problems in the technical review process, timely transform the research results into technical standards to guide the review work, improve the level of review standardization, and reduce the review discretion.

(XVII) Fully disclose the review and approval information of drugs and medical devices. Publish the drug and medical device approval list and legal basis, approval requirements and processing time limits to the public. Disclose the progress and results of drug and medical device approval to applicants. When approving a product marketing license, simultaneously publish technical review reports such as review, inspection, and testing, and accept social supervision.

III. Guarantee measures

(XVIII) Accelerate the revision of laws and regulations. Timely summarize the progress of the pilot program of the drug marketing authorization holder system and the pilot program of drug registration classification reform, and promote the accelerated revision of the "Drug Administration Law of the People's Republic of China". In conjunction with the reform of the administrative approval system, we will promptly revise the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" and the "Regulations on Drug Registration Management" according to procedures.

(19) Adjust the charging policy. Integrate and merge the registration, approval and registration fee items for drugs and medical devices. In accordance with the principle of roughly balanced revenue and expenditure, increase the registration fee standards for drugs and medical devices and adjust them every five years. Give appropriate discounts to small and micro enterprises applying for registration fees for innovative drugs and medical devices. Fee income will be included in the fiscal budget, and revenue and expenditure will be managed in two lines. The funds required for review and approval work will be arranged through the fiscal budget.

(20) Strengthen the construction of the review team. Reform the employment system of public institutions, recruit technical review talents from the society, implement contract management, and their wages and social security will be implemented in accordance with relevant national regulations. According to the needs of the review, external experts will be hired to participate in the relevant technical review, and their responsibilities, confidentiality responsibilities and conflict of interest avoidance systems will be clarified. Establish a chief professional position system, scientifically set up a position system that reflects the characteristics of technical review and inspection, clarify responsibilities, work standards and qualifications, and implement post-based employment according to the comprehensive ability and level of personnel. Promote the construction of a professional team of drug and medical device inspectors. Improve the performance appraisal system, appropriately increase the income gap according to job responsibilities and work performance, and ensure that technical reviewers and inspectors are attracted and retained. List the State Food and Drug Administration as a pilot unit for government procurement services, and entrust qualified review institutions, universities and scientific research institutions to participate in technical review work such as technical review of medical devices and generic drugs, clinical trial review, and drug safety evaluation through government procurement services.

(XXI) Strengthen organizational leadership. The State Food and Drug Administration shall, together with the Central Organization Department, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Finance, the Ministry of Human Resources and Social Security, the National Health and Family Planning Commission, the State Administration of Traditional Chinese Medicine, the General Logistics Department and the Ministry of Health, establish an inter-ministerial joint meeting system for the reform of the drug and medical device review and approval system, strengthen the coordination and guidance of the reform work, and promptly study and resolve the contradictions and problems encountered in the reform. All regions shall also strengthen the organizational leadership of the reform and report major situations to the State Council in a timely manner.

Specific news link: Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices