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European Community, drug approval

The decision by member countries of the European Community (EC) to create a single economic market by the end of 1992 has significant implications for the approval of new drugs... [Pg.165]

We recently surveyed pharmaceutical companies producing antidepressant medication or central nervous system (CNS) stimulants for the European market. Approval for use of such drugs in children and adolescents is limited worldwide. Sertraline, clomipramine, and flu-voxamine have been approved for use in children (for some drugs down to the age of 6 years) for OCD in some European countries (the most wide spread approval being for sertraline in Austria, France, Hungary, Italy, Latvia, Norway, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Denmark) and countries outside Europe. Methyl-phenidate has been approved for the treatment of children with ADHD in a number of European and non-European countries (Novartis Health care A/S, personal communication). [Pg.749]

The use of emulsifiers in foods is regulated in nearly all countries. Table 4 lists emulsifiers approved in the United States (by the Food and Drug Administration) and in Europe (by the European Economic Community). Several emulsifiers that have FDA sanction are not legally usable in Europe and vice versa. In some cases, specific limits are placed on the amount of emulsifier that a manufacturer may include in a food in other instances the limitation is that amount sufficient to produce the intended functional effect. If there is any question the appropriate regulation (in the United States, chapter 21 of the Code of Federal Regulations, 21 CFR) should be consulted. (See also Ref. 41.)... [Pg.2234]

Most European countries follow the European Directives that list the colorants and specifications for use in foods and drugs in the European Union (EU). The directive that has previously controlled the approved colorants for use in pharmaceuticals in Europe is 78/25/EEC, which refers to a list of colorants from a 1962 directive. " The EC published European Directive 94/36/EC in 1994, which significantly changed the list of approved colorants for use in foods. For example, Allura red AC (FD C red 40) and Brilliant blue FCF (FD C blue 1) were now approved for use in foods, however, these materials did not exist on the list of approved drug colorants because of the cross-referencing of the pharmaceutical directives back to the 1962 list. This has created much confusion throughout industry and the regulatory community. [Pg.660]


See other pages where European Community, drug approval is mentioned: [Pg.537]    [Pg.581]    [Pg.371]    [Pg.625]    [Pg.1685]    [Pg.245]    [Pg.232]    [Pg.609]    [Pg.843]    [Pg.904]    [Pg.108]    [Pg.110]    [Pg.164]    [Pg.165]    [Pg.168]    [Pg.261]    [Pg.734]    [Pg.904]    [Pg.363]    [Pg.86]    [Pg.300]    [Pg.374]    [Pg.140]    [Pg.7]    [Pg.532]    [Pg.1407]    [Pg.263]    [Pg.111]    [Pg.17]   
See also in sourсe #XX -- [ Pg.165 , Pg.166 ]




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Drugs approval

Drugs approved

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