In order to implement the requirements of the General Office of the CPC Central Committee and the General Office of the State Council on "Deepening the Review and Approval System Reform and Encouraging Innovation in Pharmaceutical Medical Devices" (Dongzi [2017] No. 42), the General Administration of Food and Drug Administration organized the drafting of the drug review and approval. Measures for the Administration of Information Disclosure (Draft for Comment) are now open for comments and suggestions.

The relevant units and individuals are invited to provide feedback by email before February 21, 2018.

Email: liyy@cde.org.cn.

Measures for the Administration of Drug Evaluation and Approval Information Disclosure

(draft for comment)

Chapter 1 General

Article 1 In order to improve the transparency of drug review and approval work, accept the supervision of the drug review and approval work, serve drug registration applicants and the public, and guide the industry to rational investment and research and development, in accordance with the "People's Republic of China Government Information Disclosure Regulations", These Measures are formulated on the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging Innovation in Pharmaceutical Medical Devices (Hall [2017] No. 42).

Article 2 The State Food and Drug Administration (hereinafter referred to as the General Administration of the People's Republic of China) shall disclose to the public information such as drug acceptance, review, inspection, inspection, examination and approval, and major changes after listing, and shall comply with these Measures.

Article 3 The information on the examination and approval of public drug review shall follow the principles of fairness, timeliness, accurate content, easy access and the preservation of state secrets, applicants' trade secrets and technical secrets, and personal privacy.

Article 4 The Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for the disclosure of drug review and approval information, and passes through the Drug Testing Center portal (http://www.cde.org.cn/) Open the drug review and approval information.

Chapter II Contents and Basic Requirements of Information Disclosure

Article 5 The main contents of drug review and approval information disclosure include drug registration application acceptance information, review and approval process information, review and approval results information and other review and approval information.

Article 6 The drug examination center shall establish a public information confidentiality review system, and conduct confidential examinations of state secrets, trade secrets and technical secrets in accordance with the requirements of relevant laws, regulations and regulations for the drug review and approval information to be disclosed.

Article 7 Applicants for drug registration shall cooperate with the review and approval information disclosure work, check whether there are trade secrets and technical secret information before the review and approval information is disclosed, and return the verification result to the drug examination center within the prescribed time limit.

Chapter III Acceptance of Information Disclosure

Article 8 Within 10 working days after receiving the drug registration application, the drug examination center shall, in accordance with the classification of Chinese medicine, chemical drugs and biological products, publicly register the application acceptance number, drug name, acceptance date and other information.

Article 9 The drug examination center shall regularly analyze the quality of the drug registration declaration, summarize the common problems of the declared quality, and make it public.

Article 10 The drug examination center shall regularly conduct statistical analysis on the repeated declaration of drug registration, disclose the list of more than three drugs in the same variety, and guide the applicants to conduct orderly research and rational declaration.

Chapter IV Information Disclosure in the Process of Examination and Approval

Article 11 For drugs that implement priority review, special approval and special approval procedures, the drug examination center shall publicize and explain the relevant basis for implementing the priority review, special approval and special approval procedures, and receive social supervision.

Article 12 The drug examination center shall conduct statistical analysis on the review and approval situation on a regular basis, and publicize the statistical analysis results of the time limit for reviewing various types of registration applications.

Article 13: When the drug examination center encounters a drug safety issue or a technical evaluation standard that is not clear and the guiding principles do not stipulate common problems or difficult problems, it shall further analyze and analyze, form guidance and publicize and guide Enterprise research and development.

Chapter V Review and Approval Results Information Disclosure

Article 14 For innovative drugs, improved new drugs and generic drugs approved for listing, the drug testing center shall disclose the technical review information within 60 working days after the drug is approved for listing.

Article 15 The contents of the publicly available technical review information include technical review reports, drug specifications, expert consultation and argumentation opinions, and drug inspection reports. The review report mainly covers basic information of registration applications, comprehensive review opinions, technical review conclusions and post-marketing risk control requirements. Information concerning state secrets, trade secrets, technical secrets and personal privacy is not disclosed.

Article 16 For the implementation of a conditionally approved drug for listing, the drug examination center shall disclose the specific information for conditional approval and the conditional approval of the use of the risk control plan formulated by the applicant.

Article 17 For the case of major technical disputes between the applicant and the review team, the drug review center shall disclose the handling process of major technical disputes, the opinions of the applicant, the review opinions of the review team, and the opinions of the experts. Information on the final technical review conclusions.

Article 18 For the application for conformity evaluation of enterprise declaration, the drug examination center shall disclose the conclusion of the technical review. For the varieties that pass the consistency evaluation, the product specifications, enterprise research reports and bioequivalence test data shall be disclosed to the public, and information concerning state secrets, trade secrets, technical secrets and personal privacy shall not be disclosed. For the varieties that have not passed the consistency evaluation, the reasons for not passing the decision shall be stated at the same time as the decision is not passed.

Article 19 For drugs that are newly approved for listing or through the consistency evaluation of the quality and efficacy of generic drugs, the drug examination center shall be included in the list of listed drugs in China and published, indicating the innovative drugs, improved new drugs and the quality of the original drugs. Attributes such as generic drugs with consistent efficacy, as well as information on active ingredients, dosage forms, specifications, license holders, patents acquired, and test data protection periods.

Chapter VI Disclosure of Other Review and Approval Information

Article 20 Where a drug registration applicant conducts a bioequivalence test for the record, the drug examination center shall disclose the information of the test drug, the name of the sponsor, the record number, and the test development unit after the applicant completes the record.

Article 21 If a drug registration applicant is registered for a drug clinical trial, the drug examination center shall disclose information such as the test drug, the name of the sponsor, the indication, the test development unit, the progress of the clinical trial, and the major program changes during the clinical trial. .

Article 22 The drug examination center shall establish a “API of Raw Materials Drugs”, “Database of Pharmaceutical Excipients” and “Database of Pharmaceutical Packaging Materials”, and disclose the registration information of the technical main volumes of APIs, pharmaceutical excipients and pharmaceutical packaging materials.

Article 23 The drug examination center shall promptly disclose the important information related to the safety and effectiveness of the listed drugs found in the review and the important information concerning the safety of the drug, such as the withdrawal of the drug.

Article 24 The drug examination center shall, in the first quarter of each year, publish to the public the annual report on the drug review for the previous year.

The annual report on drug review mainly includes the annual basic drug review, major work measures and progress, approval of drugs in important therapeutic areas, progress in research on drug innovations in declared varieties, analysis of declared varieties and dosage forms in key therapeutic areas, analysis of defects in registration declarations, Supplementary data factor analysis, review time limit analysis, review quality management, review trends and acceptance review, development of review institutions, and evaluation of performance evaluation.

Article 25 In addition to the acceptance of public registration applications, the process of review and approval, the results of examination and approval, and other relevant information, the drug testing center may conduct research and analysis on new issues and new trends in technical review of industry and society. .

Chapter VII Supervision and Management

Article 26 The disclosure of drug review and approval information shall be subject to social supervision, set up columns in the network to collect opinions from all walks of life, optimize the construction of information disclosure platform, and improve information disclosure.

Article 27 The General Administration shall establish an appraisal system for the disclosure of technical review information, collect opinions from all walks of life, and regularly evaluate and appraise information disclosure work.

Chapter VIII Supplementary Provisions

Article 28 These Measures shall come into force as of the date of promulgation.