European Medicines Agency , marketing

Permanand G, Mossialos E, McKee M. Regulating medicines in Europe the European Medicines Agency, marketing authorisation, transparency and pharmacovigi-lance. Clin Med 2006 6(l) 87-90. 

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

Applications to establish MRLs for new pharmacologically active substances must be submitted to the European Medicines Agency (EMEA) at least 6 months in advance of an application for a marketing authorisation. In order to avoid delays, manufacturers are advised to submit an application once all the necessary data are available, as a product authorisation carmot be granted unless established MRLs are in place. The EMEA should be notified of the intent to submit an application 3 to 4 months in advance of the anticipated date, so that a Rapporteur and Co-Rapporteur can be appointed from among the members of the Committee for Veterinary Medicinal Products (CVMP). 

Recent concerns over the arrhythmogenic effects of a number of marketed compounds have resulted in the issue of the Points to Consider document, CPMP 986/96 by the EMA (European Medicines Agency) (available at http //www.eudra/org/humandocs/PDFs/SWP/098696en.pdf). 

An application is submitted to the European Medicines Agency (EMEA). The EMEA evaluates the application and forwards its opinion (positive or negative for granting of a marketing authorization) to the European Commis-... 

Council Regulation 726/2004/EC (updates and expands the previous regulation 239/1993/EC), which mainly concerns the duties of the European Medicines Agency (EMEA), establishment of the Committee for Medicinal Products for Human Use (CHMP), and the scope and mechanisms of the centralized procedure for marketing authorization applications (MAAs) and pharmacovigilance issues. 

This chapter provides a survey of US marketed biopharmaceuticals approved over the past 20 years. It is a simply a profile of the species and types of toxicology studies done for each drug for marketing approval. For a complete list of all preclinical studies for a biopharmaceutical, the reader is directed to the Web sites of the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). 

Source The main source of the information in this table is either the Food and Drug Administration (FDA) Web site or European Medicines Agency (EMEA) Web site. For biopharmaceuticals approved before 1995 limited information is available so the author used the most recent label (package insert) to derive the reproductive, carcinogeneticity, and genetic toxicology studies completed for marketing approval. 

On March 18, 2(X)8, the European Medicines Agency granted marketing authorization for Pradaxa for the prevention of thromboanbolic disease following hip or knee replacement surgery and for nonvalvular atrial fibrillation. The FDA approved Pradaxa on October 19, 2010, for prevention of stroke in patients with non-valvular atrial fibrillation, which is currently approved in... 

Perampanel (1) represents a new class of noncompetitive AMPA receptor antagonists used for the treatment of partial-onset seizures in epileptic patients 12 and older. It is approved for marketing by the European Medicine Agency (EMA, 2011) and the Food and Drug Adminisbation (EDA, October 2012). This chapter describes in detail the pharmacological profile and chemical synthesis of perampanel. 

Sertindole was withdrawn from the market in 1998 because of a possible association with sudden or unexplained death [SEDA-26, 66]. After two observational studies did not confirm the risk, sertindole was approved in the EU in 2001, but the European Medicines Agency requested a large, postapproval commitment study to clarify the cardiac mortality risk. 

The European Medicines Agency (EMA) recommended granting marketing authorization in 2009, and eslicarbazepine is now available in most European countries as adjunct therapy for adults with refractory partial seizures. The US Food and Drug Administration announced on 2 June 2009 that it has been accepted for filing [143 ]. 

In reaction to the marketing suspension recommended by the European Medicines Agency, Genentech voluntarily withdrew efalizumab in 2009 [122 123 124 ]. 

For the application for a marketing authorisation clinical trials have to be performed. An official European body, the European Medicines Agency (EMA), assesses the therapeutic benefit risk ratio. 

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