Canada Implements ICH Guidelines on Genomic Sampling, Microsampling, Mutagenic Carcinogens

Regulatory NewsRegulatory News | 30 April 2018 |  By 

Health Canada implemented three guidelines developed by the International Council for Harmonisation (ICH) on genomic sampling and managing genomic data, microsampling, and mutagenic carcinogens.

The work on E18 Genomic Sampling and Management of Genomic data—led by the US Food and Drug Administration (FDA)—provides harmonized principles to promote consistency in interactions between drugmakers, researchers and regulators in conducting studies in the field of genomics.

“Genomic research could be used in all phases of drug development to assess genomic correlates of drug response, and to understand mechanisms of disease or drug pharmacology,” the guideline states. It was also adopted by the FDA last month, following the European Medicines Agency’s implementation on 28 February and Japan’s Pharmaceuticals and Medical Device Agency implementation on 18 January.

Health Canada became the first member of the regulatory harmonization initiative to implement the S3A Q&A on Toxicokinetics: The Assessment of Systemic Exposure – Focus on Microsampling provides—finalized in November 2017—last Thursday. The draft version was adopted by ICH in October 2016.

The focus on applying microsampling to toxicokinetics (TK) in clinical studies was prompted in response to improved analytical method sensitivity after the 1994 implementation of the S3A guideline, according to ICH. It provides “points to consider before incorporating the microsampling method in TK studies, acknowledges its benefits, and some limitations, for assessment of TKs in main study animals.”

FDA released its drafted version for industry input on the microsampling guidance in September 2016.

Further, the third ICH guideline implemented in Canada last Thursday—M7(R1)— sets forth harmonized acceptable intakes for DNA-reactive substances to limit the “potential to directly cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer,” ICH writes.

An addendum to the 2014 guideline was finalized in May 2017 and adopted by FDA last month.

Considerations for post-approval changes to a drug substance’s chemistry, elements for hazard assessment and control of process-related impurities are among the recommendations included.

Notice - ICH E18: Genomic Sampling and Management of Genomic Data
ICH S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling
Notice: ICH M7(R1): Genotoxic Impurities - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk


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