药品注册管理办法(英文版)--28号令.docx

此篇内容可在国家食品药品监督管理局网站（英语版）下载药学英语沟通群：163926581 欢迎从事医药或翻译的人加入，大家共同学习沟通Provisions for Drug Registration(SFDA Order No. 28)Provisions for Drug RegistrationChapter IGeneral ProvisionsArticle 1 The Provisions are formulated for the purposes of ensuring the safety, efficacy and quality of drugs and regulating drug registration in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), Administrative Permission Law of the People's Republic of China (hereinafter referred to as Administrative Permission Law) and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Regulations for Implementation of the Drug Administration Law).Article 2 The Provisions apply to the applications for drug clinical trial, drug production or import, and conducting drug approval, relevant testing for drug registration, or regulation thereof, within the territory of the People's Republic of China. Article 3 Drug registration refers to the process of review and approval on which the State Food and Drug Administration, in accordance with the official procedures, evaluates the safety, efficacy and quality of the drugs applied for marketing, and decides whether or not to approve such an application.Article 4 The State encourages the research and development of new drugs and adopts the special review and approval with respect to innovative drugs, new drugs for serious and life-threatening diseases and to address unmet medical needs and drugs.Article 5 The State Food and Drug Administration is in charge of drug registration nationwide, and responsible for reviewing and approving the clinical trial, production and importation of drugs.Article 6 The drug registration shall follow the principles of openness, fairness and justice.The State Food and Drug Administration adopts the system of collective responsibility of the chief reviewers, the system of publicizing and challenging relevant persons, and the system of responsibility tracing, with social supervision in such procedures as acceptance, inspection, review and approval and sending.Article 7 In the process of drug registration, the drug regulatory department shall make known to the general public, and hold hearings on, the matters which it deems of vital importance and involving public interests for the granting of permission.Prior to making the decision of administrative licensing that has a direct bearing on the vital interest between the applicant and the other party, the drug regulatory department shall inform the applicant and the interested party of their rights of requesting for hearings, making statements and argues.Article 8 The drug regulatory department shall provide the applicant with access to information on the status of the acceptance, examination, inspection, review and approval of drug registration application and the final resolution.The drug regulatory department shall publicize the following information on its official websites or at the official premises for accepting applications:(1) the items, procedures, fees and their basis, and timelines of the drug registration, index of all the data needed to be submitted and model text of the application form;(2) the name list and other relevant information on the persons involved in the acceptance, examination, inspection, review and approval of drug registration; and(3) general information about categories of approved drugs, etc.Article 9 The drug regulatory department, relevant institutions and persons involved in the drug registration have an obligation to keep the technical secrets and trial data submitted by the applicant confidential.Chapter IIApplication for Drug RegistrationArticle 10 An applicant for drug registration (hereinafter referred to as applicant) refers to the institution that submits a drug registration application and assumes corresponding legal liability.A domestic applicant shall be an institution legally registered within the territory of People's Republic of China that independently assumes civil liability and an overseas applicant shall be a legal overseas drug manufacturer. Where an overseas applicant applies for import drug registration, it shall be done by its branch or entrusted agency within the territory of People's Republic of China.The persons who handle the application for drug registration shall have professional knowledge and be familiar with the laws and regulations on, and the technical requirements for, drug registration.Article 11 Drug registration applications include applications for new drugs, generic drugs, import drugs and their supplementary applications as well as re-registration applications. Applications of domestic applicants shall be handled according to the procedures and requirements for new drugs or generic drugs, whereas applications of overseas applicants shall be han。