衛生福利部民國103年8月20日部授食字第1031201766號

預告「生物藥品檢驗封緘作業辦法」第8條、「行政院衛生署藥害救濟審議委員會審議辦法」第2條、「政府機關濫用藥物尿液檢驗實驗室設置標準」第19條、第20條、第21條、「濫用藥物尿液檢驗及醫療機構認可管理辦法」部分條文、「濫用藥物尿液檢驗作業準則」第35條、「藥物抽查及檢驗委任或委託作業辦法」第2條、「藥品優良臨床試驗準則」第2條、「藥品醫材儲備動員管制辦法」第9條、「藥害救濟申請辦法」第2條附表、「藥害救濟給付標準」第4條修正草案

MINISTRY OF HEALTH AND WELFARE Notice is hereby given, to commence a period of public comments for the draft amendment on Article 8 of "Regulations of the Lot Release Procedures for Biologics", Article 2 of "Drug Injury Relief Committee Review Regulations", Article 19, 20 and 21 of "Standards Governing the Drug Abuse Urine Testing Laboratories Established by Government Agencies", partial articles of "Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions", Article 35 of "Regulations Governing Drug Abuse Urine Testing Operations", Article 2 of "Regulations Governing Delegation or Commission of Medicaments Spot Check and Test", Article 2 of "Regulations for Good Clinical Practice", Article 9 of "Regulations Governing Reserve of Medicines and Medical Devices for Defense Mobilization", the appendix of Article 2 of "Drug Injury Relief Application Regulations" and Article 4 of "Drug Injury Relief Payment Standards"