EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined

11.03.2010

- Draft out for comments until Aug. 31, 2010 -

On March 11, 2010 the European Medicines Agency published the draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. You can find the document under http://www.ema.europa.eu/pdfs/human/bwp/53489808en.pdf

The guideline aims at harmonised requirements for the EU on the documentation on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products containing biological/biotechnology derived substances.

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