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EudraPharm
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling. The EudraPharm database was accessible to the general public and the information thus made available was worded in an appropriate and comprehensible manner. It was decommissioned in 2019. The EudraPharm database of authorised medicinal products was foreseen in thEU Regulation 726/2004 EudraPharm contained only details of products that were licensed using the Centralised procedure. Therefore, for human medicines, it was only a new interface for information that was available via the EPARs section at the EMEA. See also * European Medicines Agency * EUDRANET * EudraCT * EudraGMP * EudraVigilance EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) ... [...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] |
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 evaluation of applications. The aim of EUDRANET is to provide appropriate secure services for inter-Administration data interchange and for exchanges between Administrations and industry. EUDRANET is based on the TESTA backbone infrastructure provided by the IDA Programme. The processes which EUDRANET supports include: * The submission and evaluation of marketing authorisation applications by pharmaceutical companies; * The pharmacovigilance of products on the market to ensure the maintenance of high standards of quality as well as adhering to European national and regional regulations; * The dissemination of relevant information to industry, scientific experts and regulators. See also * eHealth * EudraCT * EudraGMP * EudraPharm * EudraVi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials registry, Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. Serious adverse event, SUSAR reports). Public Side The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own loc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraGMP
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general public, via Internet, is available since 2009 using the URL : http://eudragmp.ema.europa.eu. EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission, the European Medicines Agency and the Member State competent authorities. EudraGMP is part of a larger database known as EudraGMDP, which contains information on: * “Manufacturing and import authorisations * Good manufacturing Practice (GMP) certificates * Statements of non-compliance with GMP * GMP inspection planning in third countries” The public database allows the general public access to information regarding manufacturing inspections completed by regulatory authorities from all European Economi ... [...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] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Summary Of Product Characteristics
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly. In the United States, labelling for the healthcare practitioner is called "Prescribing Information" (PI), and labelling for patients and/or caregivers includes "Medication Guides", "Patient Package Inserts", and "Instructions for Use". In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leafl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Centralised Procedure
Centralisation or centralization (see spelling differences) is the process by which the activities of an organisation, particularly those regarding planning and decision-making, framing strategy and policies become concentrated within a particular geographical location group. This moves the important decision-making and planning powers within the center of the organisation. The term has a variety of meanings in several fields. In political science, centralisation refers to the concentration of a government's power—both geographically and politically—into a centralised government. An antonym of ''centralisation'' is ''decentralisation''. Centralisation in politics History of the centralisation of authority ''Centralisation of authority'' is the systematic and consistent concentration of authority at a central point or in a person within the organization. This idea was first introduced in the Qin Dynasty of China. The Qin government was highly bureaucratic and was administe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH into ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health And The European Union
Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organization''– ''Basic Documents'', Forty-fifth edition, Supplement, October 2006. A variety of definitions have been used for different purposes over time. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive stress. Some factors affecting health are due to individual choices, such as whether to engage in a high-risk behavior, while others are due to structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are beyond both individual and group choices, such as genetic disorders. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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