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EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. 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 trials (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 Practices. **Volume 9 - Pharmacovigilance. *Miscellaneous: **Guidelines on Good Distribution Practice of Medicinal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Directive
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before their laws are ruling on individuals residing in their countries. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter. The text of a draft directive (if subject to the co-decision process, as contentious matters usually are) is prepared by the Commission after consultation with its own and national experts. The draft is presented to the Parliament and the Council—composed of relevant ministers of member governments, initially for evaluation and comment and then subsequently for approval or rejection. Justification There are justifications for using a directive rather than a r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EUR-Lex
Eur-Lex (stylized EUR-Lex) is an official website of European Union law and other public documents of the European Union (EU), published in 24 official languages of the EU. The Official Journal (OJ) of the European Union is also published on EUR-Lex. Users can access EUR-Lex free of charge and also register for a free account, which offers extra features. History Data processing of legal texts at the European Commission started way back in the 1960s, still using punch cards at the time. A system was being developed to capture relationships between documents and analyse them to extract and re-use metadata, but also to make retrieval easier. Through the years, the system and its scope grew as the Commission started collaborating with other institutions of the European Union and as the Union started expanding. It was named CELEX (Communitatis Europae Lex) and soon became a well-used interinstitutional tool. While initially used only internally, the system went through various de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. The European EudraVigilance system deals with the: * Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2B specifications): ** EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions ( SUSARs). ** EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs. * Early detection of possible safety signals from marketed drugs for human use.CIOMS Working Group VIII. Practical aspects of signal detection in pharmacovigilance. Geneva: Council for International Organiz ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Law
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its values and the well-being of its peoples". The EU has political institutions, social and economic policies, which transcend nation states for the purpose of cooperation and human development. According to its Court of Justice the EU represents "a new legal order of international law".''Van Gend en Loos v Nederlandse Administratie der Belastingen'' (1963Case 26/62/ref> The EU's legal foundations are the Treaty on European Union and the Treaty on the Functioning of the European Union, currently unanimously agreed on by the governments of 27 member states. New members may join if they agree to follow the rules of the union, and existing states may leave according to their "own constitutional requirements".TEart 50 On the most sophisticated discu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 2005/28/EC
{{Use dmy dates, date=July 2018 The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. The directive deals with the following items: *Good clinical practice for the design, conduct, recording and reporting of clinical trials: **Good Clinical Practice (GCP) **The Ethics Committee **The sponsors * Investigator's Brochure *Manufacturing or import authorisation **Exemption for Hospital & Health Centres and Reconstitution **Conditions of Holding a Manufacturing Licence *The Trial master file and archiving **Format of Trial Master File **Retention of Essential and Medical Records *Inspectors *Inspection procedures *Final provisions References * Text of the directiveCommission D ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 2001/83/EC
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the European Union. See also * EudraLex * Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products * Directive 75/318/EEC * Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts * Directive 93/41/EEC * Directive 2001/20/EC * Regulation of therapeutic goods * European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 2001/20/EC
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 93/41/EEC
Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) and by Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations (6). See also * EudraLex * Directive 65/65/EEC1 * Directive 75/318/EEC * Directive 75/319/EEC * Directive 2001/83/EC * Regulation of therapeutic goods * European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and super ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 75/319/EEC
Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations. The Directive says that Member States shall take all appropriate measures to ensure that the documents and particulars for marketing authorization requests are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities. See also * EudraLex * Directive 75/318/EEC * Directive 65/65/EEC1 * Directive 93/41/EEC * Directive 2001/83/EC * Regulation of therapeutic goods The regulation of therapeutic goods, defined as drugs and therapeutic devices, vari ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 75/318/EEC
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations. The Directive says that Member States shall take all appropriate measures to ensure that the applications for marketing authorization, are submitted by the applicants in accordance with the guidelines of the Directive. See also * EudraLex * Directive 75/319/EEC * Directive 65/65/EEC1 * Directive 93/41/EEC * Directive 2001/83/EC * Regulation of therapeutic goods * European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicina ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
