Quality: excipients

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

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

Guidelines

• Excipients in the dossier for application for marketing authorisation of a medicinal product
• Quality of water for pharmaceutical use
• Questions and answers regarding co-processed excipients used in solid oral dosage forms