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 - Scientific guideline
- 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 - Scientific guideline
- Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products - Scientific guideline
- Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection - Scientific guideline
- ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Scientific guideline
- ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Scientific guideline
- Pharmacogenomic samples, testing and data handling - Scientific guideline
- Terminology in pharmacogenetics - Scientific guideline
- Good pharmacogenomic practice - Scientific guideline
- Co-development of pharmacogenomic biomarkers and assays in the context of drug development - Scientific guideline
- Pharmacogenetics briefing meeting - Scientific guideline
- Processing joint FDA and EMA voluntary genomic data submissions within the framework of the confidentiality arrangement - Scientific guideline