EudraLex is the collection of rules and regulations governing
medicinal products in the
European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
.
Volumes
EudraLex consists of 10 volumes:
*Concerning Medicinal Products for Human use:
**Volume 1 - Pharmaceutical Legislation.
**Volume 2 - Notice to Applicants.
***Volume 2A deals with procedures for marketing authorisation.
***Volume 2B deals with the presentation and content of the application dossier.
***Volume 2C deals with Guidelines.
**Volume 3 - Guidelines.
*Concerning Medicinal Products for human use in
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s (investigational medicinal products).
**Volume 10 - Clinical trials.
*Concerning Veterinary Medicinal Products:
**Volume 5 - Pharmaceutical Legislation.
**Volume 6 - Notice to Applicants.
**Volume 7 - Guidelines.
**Volume 8 - Maximum residue limits.
*Concerning Medicinal Products for Human and Veterinary use:
**Volume 4 -
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutic ...
s.
**Volume 9 -
Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.
The etymological roots ...
.
*Miscellaneous:
**Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Directives
*
Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
*
Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them
*
Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts
*
Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products
*
Directive 2001/20/EC, defines rules for the conduct of
clinical trials
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
*
Directive 2001/83/EC
*
Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials
See also
*
European Union law
European Union law is a system of Supranational union, supranational Law, laws operating within the 27 member states of the European Union (EU). It has grown over time since the 1952 founding of the European Coal and Steel Community, to promote ...
*
European Union directive
A directive is a legal act of the European Union that requires member states to achieve particular goals without dictating how the member states achieve those goals. A directive's goals have to be made the goals of one or more new or changed n ...
*
European Commission
The European Commission (EC) is the primary Executive (government), executive arm of the European Union (EU). It operates as a cabinet government, with a number of European Commissioner, members of the Commission (directorial system, informall ...
*
Directorate-General
Within the European Union (EU), Directorates-General are departments with specific zones of responsibility. Within the European Commission specifically, Directorates-General are the equivalent of national-level Ministry (government department), m ...
*
EUR-Lex
EUR-Lex is the official online database of European Union law and other public documents of the European Union (EU), published in 24 official Languages of the European Union, languages of the EU. The Official Journal of the European Union, Offici ...
*
Regulation of therapeutic goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...
*
*
Good clinical practice
In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for ...
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
*
EUDRANET EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and eval ...
*
EudraVigilance
*
Title 21 of the Code of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy ...
(USA)
*
Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...
References
* 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.
** Vol. 2: Notice to applicants: medicinal products for human use.
** Vol. 3: Guidelines: medicinal products for human use.
** Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use.
** Vol. 5: Pharmaceutical legislation: veterinary medicinal products.
** Vol. 6: Notice to applicants: veterinary medical products.
** Vol. 7. Guidelines: Veterinary medicinal products.
* 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
External links
News on Pharmaceuticals (European Union)
(EU DG Enterprise and Industry)
(European Commission)
{{drug control laws
European Union health policy
European Union law
Pharmaceuticals policy
National agencies for drug regulation