Der Internist
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Some emerging infectious diseases have recently become endemic in Germany. Others remain confined to specific regions in the world. Physicians notice them only when travelers after infection in endemic areas present themselves with symptoms. ⋯ Currently, West-Nile-virus infections are only imported into Germany. The timely implementation of diagnostic, therapeutic and infection control measures requires physicians to include these diseases in their differential diagnosis. To achieve this goal, good cooperation between physicians, laboratories and the public health service is essential.
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The European Clinical Trials Directive came into force on April 4th, 2001. This regulation will be implemented into the German Drug Law (AMG) through the 12th amendment to the AMG. ⋯ In particular, the procedure to gain an ethical committee's approval and permission for multicentric studies from the German Federal Authority (BfArM) will increase bureaucracy and complexity for the sponsor. The new German procedures, which by far exceed the European regulation, will lead to increased costs and will require more time for the preparation of clinical studies.