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Tag Archives: investigational medicinal products

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public consultation.

On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The draft guideline provides the principles for the two step release