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Clinical Trials:
  • The 16th law for changing of the German medicine act (AMG) came into force on October 26th 2012 ("Zweites Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften"). It implicates some new regulations for Investigators and Sponsors. The German text and further regulations for clinical trials in Germany are available under:

    Gesetze und Verordnungen
  • A summary of regulatory requirements for non-commercial clinical trials from relevant German authorities can be found on the BfArM homepage since November 2009:

    Nicht-kommerzielle Klinische Prüfungen
  • Further, actual developments can be followed on the homepage of the VFA:

    http://www.vfa.de
Quality Management:
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