https://arolstar52-zhtest.hf.space/index.php?action=history&feed=atom&title=EudraLex EudraLex - 版本历史 2026-07-17T11:57:27Z 在这个wiki上该页的修订历史 MediaWiki 1.43.9 https://arolstar52-zhtest.hf.space/index.php?title=EudraLex&diff=2117257&oldid=prev imported>Aronlee90：​使用HotCat已移除Category:藥物監管機構; 已添加Category:国家药品监管机构 2025-02-07T09:28:48Z <p>使用<a href="/index.php?title=WP:HOTCAT&amp;action=edit&amp;redlink=1" class="new" title="WP:HOTCAT（页面不存在）">HotCat</a>已移除<a href="/index.php?title=Category:%E8%97%A5%E7%89%A9%E7%9B%A3%E7%AE%A1%E6%A9%9F%E6%A7%8B&amp;action=edit&amp;redlink=1" class="new" title="Category:藥物監管機構（页面不存在）">Category:藥物監管機構</a>; 已添加<a href="/wiki/Category:%E5%9B%BD%E5%AE%B6%E8%8D%AF%E5%93%81%E7%9B%91%E7%AE%A1%E6%9C%BA%E6%9E%84" title="Category:国家药品监管机构">Category:国家药品监管机构</a></p> <p><b>新页面</b></p><div>{{Politics of the European Union}}<br /> &#039;&#039;&#039;EudraLex&#039;&#039;&#039;是[[歐盟]]一系列關於[[藥物]]規則和規章。<br /> <br /> ==分冊==<br /> EudraLex共分10冊：<br /> *有關人類用的藥物分冊：<br /> **第1冊 - 製藥法例<br /> **第2冊 - Notice to Applicants.<br /> ***第2A冊 deals with procedures for marketing authorisation.<br /> ***第2B冊 deals with the presentation and content of the application dossier.<br /> ***第2C冊 deals with Guidelines.<br /> **第3冊 - 指引<br /> <br /> *有關人類用藥物的[[臨床試驗]]<br /> **第10冊 - [[臨床試驗]]<br /> <br /> *有關動物用的藥物：<br /> **第5冊 - 製藥法例<br /> **第6冊 - Notice to Applicants.<br /> **第7冊 - 指引<br /> **第8冊 - 最大殘留限制<br /> <br /> *有關人畜共用的藥物：<br /> **第4冊 - [[良好生產規範]]<br /> **第9冊 - {{tsl|en|Pharmacovigilance|藥物安全}}<br /> <br /> *其他：<br /> **Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)<br /> <br /> ==指令==<br /> <br /> ==參見==<br /> *[[歐盟法律]]<br /> *[[歐盟指令]]<br /> *[[歐洲理事會]]<br /> *{{tsl|en|EUR-Lex|EUR-Lex}}<br /> *[[良好藥品臨床試驗規範]]<br /> *[[歐洲藥物管理局]]<br /> *{{tsl|en|EUDRANET|EUDRANET|歐盟藥物管理機構網絡}}<br /> *{{tsl|en|EudraVigilance|歐盟藥物警戒系統}}<br /> *{{tsl|en|Title 21 of the Code of Federal Regulations|聯邦規章典集第21篇}}（美國）<br /> <br /> ==參考資料==<br /> * Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. <br /> ** Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7<br /> ** Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X<br /> ** Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5<br /> ** Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7<br /> ** Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8<br /> ** Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5<br /> ** Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3 <br /> * Markus Hartmann and Florence Hartmann-Vareilles, &#039;&#039;The Clinical Trials Directive: How Is It Affecting Europe&#039;s Noncommercial Research?&#039;&#039;, PLoS Clin Trials. 2006 June; 1(2): e13<br /> {{reflist}}<br /> <br /> == 外部链接 ==<br /> * [https://web.archive.org/web/20100413104348/http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm News on Pharmaceuticals], (European Union) <br /> * [http://ec.europa.eu/health/documents/eudralex/index_en.htm EudraLex]{{Wayback|url=http://ec.europa.eu/health/documents/eudralex/index_en.htm |date=20160311001011 }}<br /> * [http://eur-lex.europa.eu/en/index.htm EUR-Lex]{{Wayback|url=http://eur-lex.europa.eu/en/index.htm |date=20130410194708 }}<br /> * [https://web.archive.org/web/20061021073704/http://ec.europa.eu/enterprise/pharmaceuticals/review/index.htm Review of pharmaceutical legislation] (EU DG Enterprise and Industry)<br /> * [https://web.archive.org/web/20130421021032/http://ec.europa.eu/enterprise/index_en.htm Directorate General Enterprise and Industry] (European Commission)<br /> <br /> {{-}}<br /> {{歐洲聯盟法律}}<br /> <br /> [[Category:臨床研究]]<br /> [[Category:歐盟法律]]<br /> [[Category:製藥政策]]<br /> [[Category:国家药品监管机构]]<br /> <br /> {{卫生小作品}}</div> imported>Aronlee90