Quality: pharmaceutical development

The European Medicines Agency's scientific guidelines on pharmaceutical development 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

• Quality requirements for drug-device combinations
• Development pharmaceutics
• ICH Q8 (R2) Pharmaceutical development
• ICH Q9 Quality risk management
• ICH Q10 Pharmaceutical quality system
• ICH Q8, Q9 and Q10 - questions and answers
• Pharmaceutical development of medicines for paediatric use
• Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need

Reflection paper

• Pharmaceutical development of medicines for use in the older population

Concept paper

• Development of a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product