Multidisciplinary guidelines: pharmacogenomics

The European Medicines Agency's scientific guidelines on pharmacogenomics (PG) help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

PG considerations during drug life cycle

• Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
• Addendum on terms and concepts of pharmacogenomic features related to metabolism to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
• Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
• Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection

Guidance on technical PG aspects

• ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
• ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions
• Pharmacogenomic samples, testing and data handling
• Terminology in pharmacogenetics
• Good pharmacogenomic practice

Therapeutic-specific PG guidance

• Pharmacogenomics in oncology

Procedural guidance

• Co-development of pharmacogenomic biomarkers and assays in the context of drug development
• Pharmacogenetics briefing meeting
• Processing joint FDA and EMA voluntary genomic data submissions within the framework of the confidentiality arrangement