NEW YORK (GenomeWeb News) — The International Conference on Harmonization has finalized a set of definitions it will publish as a guideline in May that may be used by international scientists, companies, and regulators in assessing pharmacogenomics products and services.
The ICH is a joint effort led by the European Medicines Agency’s Committee for Medicinal Products for Human Use and includes the input of the US Food and Drug Administration.
The ICH has worked with regulators in Europe, North America, and Japan through a project called “Technical Requirements for Registration of Pharmaceuticals for Human Use” to develop definitions that will help facilitate the inclusion of pharmacogenomics and pharmacogenetics into drug development and approval processes.
The ICH started the project to remedy the inconsistency of applied definitions, which could lead to conflicting usage and interpretations by regulators, industry, investors, and ethics groups.
The ICH expects the definitions to be published without change in May, although it is still awaiting review from the FDA, the EMEA said through the ICH’s Secretariat office. The guideline defines pharmacogenomics, pharmacogenetics, genomic biomarkers, and other related terms.
According to the guideline:
Pharmacogenomics is “the study of variations of DNA and RNA characteristics as related to drug response.”
Pharmacogenetics, a sub-set of pharmacogenomics, is “the study of variations in DNA sequence as related to drug response.”
A genomic biomarker is defined as “a measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions,” and be a measurement of the expression of a gene, the function of a gene, or the regulation of a gene. A genomic biomarker may consist of DNA and/or RNA characteristics.
DNA characteristics include SNPs, short sequence repeats, haplotypes, DNA methylation, SNP deletions or insertions, copy number variations, and rearrangements such as translocations, duplications, deletions, or inversions.
RNA characteristics include sequences, expression levels, and splicing, among others.
Genomic biomarkers are not limited to human samples, but may include samples from viruses and infectious agents as well as animal samples.
A drug should be considered synonymous with an investigational product, medicinal product, and medicine and pharmaceutical product, such as vaccines or other products.
The definitions of PGx and PGt do not include other disciplines such as proteomics and metabalomics.
Drug response will include the process of drug absorption and disposition, and drug effects, drug efficacy, and adverse effects of drugs.