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European Medicines Evaluation Agency requirements

Membership of the European Union and the establishment of the European Medicine Evaluation Agency (EMEA) have added a European dimension to monitoring of adverse drug reactions in the UK and given it a new title of pharmacovigilance . The requirements arising from the European dimension are summarised later. [Pg.601]

The consequences for the scientific assessment of study validity did induce the European Medicines Evaluation Agency and its Committee for Proprietary Medicinal Products (EMEA/CPMP) to issue a draft guideline to deal with this problem of control sample contamination (CPMP, 2004). In this draft guideline reference is made to the GLP Principles and their requirement of fully, and truthfully, representing all results from a study, and the guideline stresses what is required for a GLP-compliant study report as follows The contamination of control samples with the test compound in toxicology studies shall be reported appropriately within a GLP statement as a deviation or violation. Contamination of controls should also be clearly acknowledged in the study reports and discussed by the Study Director with respect to its impact on the validity ofthe study. ... [Pg.19]

The features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... [Pg.1454]

The promotional material must not include references to the National Organisation for Medicines (EOF), the European Medicines and Evaluation Agency (EMEA) and the committees operating under the responsibility thereof, or under the responsibility of the Ministry of Health, unless this is required by the competent authorities. [Pg.155]

The EU Directive 92/18/EEC [122] introduced for the first time the requirement for an ERA, as a prerequisite to obtain marketing authorization for veterinary pharmaceuticals. For this purpose, the European Agency for the Evaluation of Medicinal Products (EMEA) published a Note for Guidance where guidelines to assess the environmental risk of veterinary medicinal products are established [123]. [Pg.231]


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Agency requirements

European Medicinal Evaluation Agency

European Medicines

European Medicines Evaluation

European Medicines Evaluation Agency

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