title: [Clinical research with pharmaceutical agents in Germany: effects of the 12th amendment to the German Drug Law].
abstract: 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. It will impose major changes on the preparation and conduct of clinical studies with medicaments. 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.
authors.affiliation: Sprecher der Korporativen Mitglieder der Deutschen Gesellschaft für Innere Medizin. Dieter.Goette@aventis.com
authors.forename: D
authors.initials: D
authors.lastname: Götte
authors.forename: T R
authors.initials: TR
authors.lastname: Weihrauch
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence*; D003365:Costs and Cost Analysis / Q000706:statistics & numerical data; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D017041:Ethics Committees / Q000331:legislation & jurisprudence; D005380:Financing, Government / Q000191:economics / Q000331:legislation & jurisprudence; D005858:Germany; D006801:Humans; D009313:National Health Programs / Q000191:economics / Q000331:legislation & jurisprudence*; D012109:Research Support as Topic / Q000191:economics / Q000331:legislation & jurisprudence
chemical_list: D015507:Drugs, Investigational