1. 6/23/2017:宣導洗錢防制法
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中心中文影片簡介
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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!!
    . 丹麥
    10/29/2002 天然藥物註冊——申請人指南
    . 歐盟
    12/9/2013 (EMA)Concept paper on the development of product-specific guidance on demonstration of bioequivalence
    11/29/2013 EMA發表「尿失禁治療藥品之新藥研發指引」
    11/5/2013 2013年歐盟出版植物藥與傳統植物藥問答集
    6/4/2013 2013年歐盟發表「控釋製劑之藥動與臨床評估」指引草案
    5/31/2013 歐洲藥品管理局(EMA)擬修改鄰苯二甲酸鹽限值
    3/3/2011 Guideline on missing data in confirmatory clinical trials
    1/3/2011 Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies
    3/31/2010 1. European Generic Medicines Association (EGA)針對現行歐洲藥證審查程序常見問題提出建議 1點
    11/16/2009 Conduct of inspections of Pharmaceutical manufacturers
    11/16/2009 Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries
    4/21/2009 體外診斷醫療器材之共同技術規格決議
    4/21/2009 G/TBT/N/EEC/216/Add.1關於歐盟法規(EC)1907/2006號化學物質之註冊、評估、授權與限制(REACH)附錄XI之修正法規
    3/25/2009 Guideline on the non-clinical development of fixed combinations of medicinal products
    11/3/2008 CONCEPT PAPER ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING RECOMBINANT ALPHA-INTERFERON
    11/3/2008 GUIDANCE ON SIMILAR MEDICINAL PRODUCTS CONTAINING RECOMBINANT ERYTHROPOIETINS
    10/8/2008 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE:Quality issues
    10/8/2008 Guideline on similar biological medicinal product
    10/8/2008 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE:NON-CLINICAL AND CLINICAL ISSUES
    10/2/2008 MUTUAL RECOGNITION CO-ORDINATION GROUPS ESTABLISHED BY DIRECTIVES 2004/27/EC AND 2004/28/EC
    7/24/2007 歐盟調和新化學品政策(REACH法案)
    12/1/2006 Regulation (EC) No 178/2002 of the EU and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
    12/1/2006 2002/99/EC the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption
    12/1/2006 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
    11/20/2006 歐盟執委會公告「醫療器材」指令規定之最新版「調和標準」及被取代或修正之前標準其被推定視為符合性之終止適用日期
    11/20/2006 歐盟第98/79/EC號「體外診斷醫療器材IVD」指令規定之新修正最新版「調和標準」
    11/20/2006 歐盟執委會公告「主動式植入醫療器材」指令規定之最新版「調和標準」及被取代或修正之前標準其被推定視為符合性之終止適用日期
    11/1/2006 Guidance on quality of herbal medicainal products / traditional herbal medicinal products
    9/14/2006 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004
    8/8/2006 White Paper on Food Safety(食品安全白皮書)
    6/26/2006 GUIDELINE ON GOOD AGRICULTURAL AND COLLECTION PRACTICE (GACP) FOR STARTING MATERIALS OF HERBAL ORIGIN
    3/20/2006 Guidance on Biosimilar Medicinal Products Containing Recombinant Erythropoietins
    2/23/2006 2004-27-EC(人用藥指令)
    5/17/2004 歐盟傳統草藥法
    4/15/2004 歐盟新藥分散式審查程序明年生效 0點
    4/8/2003 歐盟中藥及中藥保健品進口程序及要求 10點
    3/4/2003 取得EMEA藥物證明書流程圖 10點
    1/27/2003 歐盟植物藥重要審查依據及相關法規 50點
    1/1/2002 歐洲各國對天然物的法令及規範 250點
    . 法國
    2/25/2004 法國關於申請草藥銷售許可的通知
    . 瑞典
    . 英國
    11/3/2011 Guidance for Retailers, Wholesalers, Importers and Manufacturers on the Requirements of the THMRS
    12/17/2008 英國--新藥品價格規範計畫(PPRS)