On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data. The Guideline takes effect on 28 February 2018.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) developed the Guideline in acknowledgement of the growing awareness of, and interest in, genomic data generated from clinical studies. The ICH suggested that the absence of a harmonized guideline made it more difficult to conduct genomic research consistently in global studies. The fact that the CHMP has adopted the Guideline means that EU guidance on this subject is now aligned with the ICH standard.
The Guideline provides general principles for the collection and handling of genomic samples and management of genomic data. It also affirms broader principles, such as the need for informed consent and the protection of subjects’ privacy etc. The Guideline applies to both interventional and non-interventional clinical studies, irrespective of when the genomic research is carried out and whether it was envisaged in the study protocol. The ICH/CHMP intend the Guideline to be interpreted in accordance with the law and policies in each jurisdiction where genomic research takes place.
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