EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
07.05.2012
- final Guideline released; applicable since April 15, 2012-
The European Medicines Agency published the final 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/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127370.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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