1. 6/23/2017:宣導洗錢防制法
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 公告區
中心中文影片簡介
中心英文影片簡介
公告徵求有意進入國際市場之國產藥品,專案提供高值化藥品國際化法規輔導...(2017/9/12)
106年度「高值製藥產業國際鏈結推升計畫」之「台灣生技醫藥資訊平台網站建置」招標公告...(2017/8/4)
106年度經濟部工業局製藥產業轉型升級計畫提案說明會暨商談會...(2017/6/9)

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藥技中心參與行政院生技
高階人才培訓與就業計畫



  • 獲頒感謝狀!!
    . 美國
    2/7/2014 FDA公佈「學名藥錠劑與膠囊尺寸、形狀及其他物理性質」指引草案
    12/20/2013 FDA(DRAFT GUIDANCE) :Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
    12/19/2013 FDA and European Medicines Agency launch generic drug application inspections initiative
    11/26/2013 FDA Form 356h and Form 2253
    11/7/2013 FDA:Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment 10點
    10/30/2013 Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products 10點
    9/25/2013 For Fiscal Year 2014 Generic Drug User Fee Amendments Regulatory Research Priorities 10點
    8/5/2013 無麩質食品 美訂定標示準則
    5/21/2012 美國強化營養補充品(dietary supplement)管理 引發業界強力反彈!
    4/2/2012 Classifying Significant Postmarketing Drug Safety Issues
    3/19/2012 Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
    3/19/2012 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
    3/6/2012 Guidance for Industry Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
    3/6/2012 Guidance for Industry Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
    11/1/2011 Residual Drug in Transdermal and Related Drug Delivery Systems
    8/1/2011 Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications
    5/3/2011 Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB)
    2/9/2011 Process Validation: General Principles and Practices
    2/8/2011 Qualification process for Drug development tools
    12/1/2010 Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
    11/22/2010 CMC Postapproval Manufacturing Changes Reportable in Annual Reports
    11/22/2010 Investigational New Drug Applications (INDs)— Determining Whether Human Research Studies Can Be Conducted Without an IND
    11/22/2010 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
    11/22/2010 Guidance for Industry Bioequivalence Recommendations for Specific Products
    7/1/2010 CGMP法規協和化議題 1點
    7/1/2010 2010年3月美國綜合法規整理 1點
    6/8/2010 Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment
    5/4/2010 Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
    12/3/2009 Residual Solvents in Drug Products Marketed in the United States
    11/16/2009 Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002 (1/2)
    11/16/2009 Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002 (2/2)
    10/13/2009 ANDAs--Impurities in Drug Substances
    2/6/2009 Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
    9/10/2008 Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
    8/20/2008 Computerized Systems Used in Clinical Trials
    1/2/2008 Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
    10/26/2007 MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003
    10/19/2007 聯邦公報(Federal Register Vol. 66, No. 228)進口人類用藥、動物用藥、生物製劑與醫療器材到美國境內的外國廠商相關規定
    10/8/2007 Pharmacogenomic data submissinons-companion guidance
    9/27/2007 ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
    1/3/2007 Guidance for Industry Botanical Drug Products
    1/2/2007 Current Good Manufacturing Practice for Combination Products
    10/3/2006 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
    9/1/2006 Guidance for Industry Patient-Reported Outcome Measures: Medical Product Development to Support Labeling Claims 0點
    2/15/2006 Prescription Drug User Fee Amendments of 2002
    1/9/2006 Guidance for Industry Analytical Procedures and Methods Validation-1/2
    1/9/2006 Guidance for Industry Analytical Procedures and Methods Validation-2/2
    12/8/2005 Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers
    8/12/2005 Drug Price Competition and Patent Term Restoration Act of 1984
    8/1/2005 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
    4/26/2005 A Dietary Supplement Labeling Guide
    9/20/2004 Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
    5/12/2004 Guidance for Industry Botanical Drug Products--下
    5/12/2004 Guidance for Industry Botanical Drug Products--上
    4/9/2004 cGMP IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS
    12/15/2003 INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information
    12/15/2003 BA and BE Studies for Orally Administered Drug Products —General Considerations
    12/15/2003 Guidance for Industry Bioanalytical Method Validation
    10/28/2003 cGMP in Manufacturing, Packing, or Holding Dietary Ingredinets and Dietary Supplements; Proposed Rule
    10/2/2003 FDA因應生物恐怖主義法案規章即將發佈
    7/18/2003 美國新規定食品包裝應標示「轉換脂肪酸」含量
    6/17/2003 美國FDA--利嘔吐藥 吐根(ipecac)糖漿 應改列處方藥
    5/5/2003 美國反生物恐怖法(BIOTERRORISM ACT)對台灣食品﹐飲料﹐中草藥及營養補充品的影響
    5/2/2002 美國膳食補充品健康與教育法 0點
    1/1/2002 美國食品藥物管理局對植物性產品之規範 200點
    1/1/2002 美國食品藥物管理局的膳食補充品指引 100點
    1/1/2002 有關美國輸入中藥規定及市場概況 100點
    1/1/2002 植物性產品的規則—歐美間的差異 100點
    1/1/2002 膳食補充品(dietary supplements)標示規定 100點
    1/1/2002 美國食品藥物管理局嚐試釐清膳食補充品可允許陳述 100點
    . 加拿大
    5/5/2008 GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
    11/21/2005 TRADITIONAL HERBAL MEDICINES (Revised) -1995
    11/21/2005 GMP Interpretation Decision Records - 2003 Edition
    11/21/2005 REGULATIONS AMENDING THE NATURAL HEALTH PRODUCTS REGULATIONS (SPECIAL ACCESS)
    10/27/2005 Natural Health Products Regulations-2/2
    10/27/2005 NATURAL HEALTH PRODUCTS REGULATIONS-1/2
    5/21/2004 加拿大--《天然保健産品管理條例》
    4/13/2004 Good Manufacturing Practices Guidenlines
    2/25/2004 食品及醫藥品管理法規
    2/25/2004 食品及藥品法規索引
    2/25/2004 加拿大藥品生産質量管理規範