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.
- 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
- 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