European Medicines

OC-Bisabolol. a-Bisabolol (99) occurs in camomile flowers and has been shown to be the main antiphlogistic and spasmolytic component of the European medicinal plant. The use of bisabolol is recommended mainly for its pharmacodynamic properties in cosmetic preparations for skin protection. 

It is over three centuries since cinchona bark came into use in European medicine, and no other natural drug has had so much written about it. There are the stories, sometimes legendary, of its discovery by Europeans, vigorous early discussions of its therapeutic value, the destruction of the S. American cinchona trees to meet the demand for bark, the labours of botanical explorers in collecting seed for the formation of plantations, the establishment and development of these plantations in Ceylon, India and Java, the competition between them, the gradual emergence of Java as the world s most important source of supply of cinchona bark, and the development of the manufacture of quinine sulphate in Europe, the United States and the Tropics. ... 

IV The European Medicines Agency - responsibilities and administrative structures... 

The mission of the European Medicines Agency is to foster scientific exceiience in the evaluation and supervision of medioines, for the benefit of public and animal health. 

Working with the Member States and the European Commission as partners in a European medioines network, the European Medicines Agency ... 

European Commission, Enterprise and Industry Directorate-General http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. http //ec.europa.eu/enterprise/medical devices/index en.htm. European Medicines Agency... 

European Medicines Agency non-harmonised guidance documents http //www.emea.europa.eu/htms/human/humanguidelines/nondinical.htm. 

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... 

Classical examples of anti-inflammatory Asteraceae are Arnica montana and Calendula officinalis, both used in European medicine to treat bruises and contusions. There is an expanding body of evidences to suggest that Asteraceae could be a useful source of anti-inflammatories, such as sesquiterpene lactones and/or triterpene alcohols, the latter being known to inhibit 12-O-tetra-decanoylphorbol-13-acetate (TPA)-induced inflammation in mice as efficiently as commercial indomethacine by possible inhibition of phospholipase A2 (10). 

Wake G, Court J, Pickering A, Lewis R, Wilkins R and Perry E (2000). CNS acetylcholine receptor activity in European medicinal plants traditionally used to improve failing memory. Journal of Ethnopharmacology, 69, 105-114. 

The European Medicines Agency and the new EU drug approval systems... 

Annual Report of European Medicines Agency, March 2007, p. 103. 

Christians U, First MR, Benet LZ (2000) Recommendations for bioequivalence testing of cyclosporine generics revisited. Ther Drug Monit 22 330-335 CPMP (2000) European Medicines Agency. Committee for Proprietary Medicinal Products. Note for guidance on the investigation on bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98.http //www.emea.europa.eu/pdfs/human/qwp/140198en.pdf. Cited 30 Dec 2008... 

EU (2001) EU directive 2001/83/EC. http //eur-lex.europa.eu/LexUriServ/site/en/consleg/2001/L/ 02001L0083-20070126-en.pdf. Cited 30 Dec 2008 EMEA (2008) European Medicines Agency. EPARs for authorised medicinal products for human use. http //www.emea.europa.eu/htms/human/epar/a.htm. Cited 30 Dec 2008 ICH (2008) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http //www.ich.org. Cited 30 Dec 2008 ISMP (2005) The Institute for Safe Medication Practices. List of confused drug names. http //www.ismp.org/Tools/confuseddrugnames.pdf. Cited 30 Dec 2008... 

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). 

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