Revised EU GMP Guidelines for IMPs

The EU have published revised GMP guidelines for investigational medicinal products which will come into effect on the application date of the Clinical Trial Regulation (536/2014), which is currently expected to be 2H2019.  The document is in EudraLex Volume 10 (not 4), Chapter III: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf

 

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