freepeople性欧美熟妇, 色戒完整版无删减158分钟hd, 无码精品国产vα在线观看DVD, 丰满少妇伦精品无码专区在线观看,艾栗栗与纹身男宾馆3p50分钟,国产AV片在线观看,黑人与美女高潮,18岁女RAPPERDISSSUBS,国产手机在机看影片

正文內(nèi)容

最新藥品注冊(cè)管理辦法word版-展示頁(yè)

2024-08-22 22:05本頁(yè)面
  

【正文】 .................... 1Chapter 1: General Principles .................................................................................. 2 Chapter 2: Basic Requirements................................................................................ 4 Chapter 3: Clinical Trials of Drugs ............................................................................ 7 Chapter 4: Application and Approval of New Drugs ................................................11 Section 1: Clinical Trials for New Drugs ............................................................. 12Section 2: Production of New Drug..................................................................... 13Section 3: Monitoring Period of New Drugs ....................................................... 15Chapter 5: Application and Approval of Generic Drugs ............................................... 16Chapter 6: Application and Approval for Imported drugs........................................... 18 Section 1: Registration of Imported drugs............................................................. 18Section 2: Approval of Repackaging of Imported drugs ....................................... 20Chapter 7: Application of OTC Drugs ..................................................................... 21 Chapter 8: Supplemental Application and Approval ............................................... 22 Chapter 9: Reregistration of Drugs........................................................................ 24 Chapter 10: Inspection During Drug Registration ..................................................... 25 Chapter 11: Drug Registration Standards and Insert Sheets .................................... 27 Section 1: Drug Registration Standards ................................................................ 27Section 2: Drug Standard Substance .................................................................... 27Section 3: Drug Name, Insert Sheets and Labels................................................. 281/107/Drug Registration Regulation (SFDA Order 28)Chapter 12: Prescribed Timeline ............................................................................ 28 Chapter 13: Reconsideration.................................................................................. 31 Chapter 14: Legal Liability ...................................................................................... 32 Chapter 15: Miscellaneous ..................................................................................... 34Annex 1: Registration Categories and Application Information Requirements of TCMand Natural Drugs ..................................................................................................... 36Annex 2: Registration Categories and Application Information Requirements ofChemical Drugs......................................................................................................... 48Annex 3: Registration Categories and Application Information Items Requirements ofBiological Products.................................................................................................... 67Annex 4: Registration Items and Application Information Requirements ofSupplemental Application of Drug Registration......................................................... 90Annex 5: Application Information Items of Drug ReRegistration ............................ 102Annex 6: Timeframe for monitoring period of New Drugs ...................................... 105 Chapter 1: General PrinciplesArticle 1: This Regulation is promulgated according to the Drug Administration Lawof The People’s Republic of China (Drug Administration Law), AdministrativeLicensing Law of The People’s Republic of China (Administrative Licensing Law), andthe Implementing Regulation of the Drug Administration Law of The People’s Republicof China (Implementing Regulation) to ensure the safety, efficacy and quality control of drugs and standardize drug registration.Article 2: This Regulation shall apply to all drug research and clinical studies,application for clinical study, drug production and / or importation, as well as the drugapproval review, registration inspection and drug administration in The People’s Republic of China (PRC).2/107/Drug Registration Regulation (SFDA Order 28)Article 3: Drug registration means the legal process by which a decision is made bySFDA, upon application of registration applicant, to either approve or not approve theconducting of a drug clinical trial, production or importation of a drug to be marketed,based on a systematic evaluation of the safety, efficacy and quality control of the drug. Article 4: The State shall encourage research and development of new drugs and exercise the approval via a special process of innovative new drugs, those for difficultto treat and life threatening diseases.Article 5: The State Food and Drug Administration (SFDA) is the petent national authority for drug registration, responsible for the review and approval of clinical studies, production and importation of drugs. Article 6: Drug registration should follow the principles of openness equality,fairness, and for the convenience of the publics. During drug registration, SFDA shall apply the systems of joint responsibility of thepresiding reviewer, public disclosure and rescuing of the related staff, responsibilityinvestigation for any wrongdoing, in order to administer the steps from acceptance,inspection, review, approval, through delivery, and subject to monitoring by the publics. Article 7: During drug registration, should the drug administrative authority considerany permitting issues of significant interest to the publics, the issu
點(diǎn)擊復(fù)制文檔內(nèi)容
環(huán)評(píng)公示相關(guān)推薦
文庫(kù)吧 www.dybbs8.com
備案圖鄂ICP備17016276號(hào)-1