On 23 May 2018, the European Medicines Agency (EMA) released a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs) for public consultation.
The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.
The document complements the Delegated Regulation (EU) No 2017/1569 of 23 May 2017, on good manufacturing practice (GMP) for investigational medicinal products (IMP) and arrangements for inspections, and the detailed Commission guidelines No C(2017) 8179 on good manufacturing practice for investigational medicinal products for human use.
The deadline for comments is set on 31 August 2018. Please refer to the title page of the draft guideline for more information regarding the template to be used and the appropriate email address.