EudraLex

EudraLex是歐盟一系列關於藥物規則和規章。

分冊
EudraLex共分10冊：
有關人類用的藥物分冊：
第1冊 - 製藥法例
第2冊 - Notice to Applicants.
第2A冊 deals with procedures for marketing authorisation.
第2B冊 deals with the presentation and content of the application dossier.
第2C冊 deals with Guidelines.
第3冊 - 指引

有關人類用藥物的臨床試驗
第10冊 - 臨床試驗

有關動物用的藥物：
第5冊 - 製藥法例
第6冊 - Notice to Applicants.
第7冊 - 指引
第8冊 - 最大殘留限制

有關人畜共用的藥物：
第4冊 - 良好生產規範
第9冊 - 

其他：
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

指令

參見
歐盟法律
歐盟指令
歐洲理事會

良好藥品臨床試驗規範
歐洲藥物管理局

（美國）

參考資料
 Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.  
 Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7
 Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
 Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5
 Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7
 Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8
 Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5
 Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3  
 Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?, PLoS Clin Trials. 2006 June; 1(2): e13

 外部链接 
 News on Pharmaceuticals, (European Union) 
 EudraLex
 EUR-Lex
 Review of pharmaceutical legislation (EU DG Enterprise and Industry)
 Directorate General Enterprise and Industry (European Commission)

Category:臨床研究
Category:歐盟法律
Category:製藥政策
Category:国家药品监管机构