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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 on the BfArM homepage.
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A summary of regulatory requirements for non-commercial clinical trials from relevant German authorities
can be found on the BfArM homepage since November 2009 also.
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Further, actual developments can be followed on the homepage of the VFA.
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Quality Management:
- Legal regulations for quality management in parts of the German health system are summarized on KBV homepage.
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