European Medicines Agency EMEA

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). 

Two forms of pegylated IFN-a have been approved by the Food and Drug Administration (FDA) and by the European Medicines Agency (EMEA) for the... 

European Medicines Agency (EMEA) of the European Union... 

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-... 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

Eurther to this directive, the European Medicines Agency (EMEA) began, in 2001 [98], to outline a feasible risk assessment scheme, which was later published in a draft form in 2003 [50] in 2006 [51], the following five-step procedure was adopted, with a view to guaranteeing that possible long-term and low-level effects of the new substances are not overlooked this procedure is also used in the licensing of new compounds (including pharmaceuticals). 

FTIH trials are discussed in the Guideline on strategies to identify and mitigate risks for first-in human clinical trials with investigational medicinal products, EMEA/CHMP/SWP/28367/07issued by the European Medicines Agency (EMEA), in 2007. 

European Medicines Agency (EMEA) PAT web site http //www.emea.eu.int/ Inspections/PAThome.html... 

Vinblastine (6.73) is an antimitotic drug that prevents polymerization of tubulin (Figure 6.26). When incubated with tubulin, vinblastine complexes in a 1 1 ratio with tubulin proteins. By blocking polymerization, vinblastine prevents microtubule formation and therefore mitosis. In contrast, paclitaxel (Taxol, 6.74) and epothilone B (6.75) stabilize aggregated tubulin. As a result, in the presence of paclitaxel and epothilone B, cells form static bundles of microtubules that are nonfunctional. Vinblastine and paclitaxel are both approved for clinical use against cancer. Ixabepilone (6.76), an analogue of epothilone B (6.75), has been approved by the FDA for treatment of certain forms of breast cancer. The European Medicines Agency (EMEA) did not approve ixabepilone out of concern over severe side effects.27... 

Since the first introduction of insulin to treat diabetic patients in 1923, much effort has been made to seek alternative convenient and painless routes for insulin administration instead of daily injections. In this respect the pulmonary route has received the most attention, and substantial evidence has shown inhaled insulin to be an effective, well-tolerated, noninvasive alternative route [53-56]. Insulin therapy is required for patients with type 1 diabetes. Although some patients with type 2 diabetes can control their disease with oral antidiabetics, many will eventually also require insulin. Thus, inhaled insulin shows promise for type 2 diabetic patients [54, 56]. There are two principal inhalation systems for insulin, namely aqueous solution and dry powder. The dry powder form (Exubera ) has been approved by FDA and the European Medicines Agency (EMEA) in January 2006. 

Given that there are 27 independent states involved in the EU with three states, Iceland, Liechtenstein, and Norway from the European Economic Commu-nity-European Free Trade Area (EEC-EFTA), it is important that the European Medicines Agency (EMEA) and the European parliament enact regulations that will meet the needs of the peoples of the member nations relative to new medicinal advances. The founding legislation of the European Medicine Agency is found in Regulation (European Commission) No. 726/2004. The headquarters of the EMEA is located in London. 

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