ICH E18: Genomic Sampling and Management of Genomic Data

Author: Bhavesh Patel, C. Chem.

Health Canada recently announced the implementation of ICH guidance E18: Genomic Sampling and Management of Genomic Data (the “Guidance”).

The Guidance was developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

The main objective of the Guidance is to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The Guidance facilitates the implementation of genomic studies by enabling a common understanding of critical parameters for the unbiased collection, storage, and optimal use of genomic samples and data. The Guidance also intends to increase awareness and provide a reminder regarding subjects’ privacy, protection of the data generated, the need to obtain suitable informed consent, and the need to consider transparency of findings in line with local legislation and regulations. The Guidance is intended to foster interactions amongst stakeholders, including drug developers, investigators and regulators, and to encourage genomic research within clinical studies.

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Reference:

1.      http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E18/E18EWG_Step4_Guideline_2017_0803.pdf