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.
- Quality documentation for medicinal products when used with a medical device - Scientific guideline
- Development pharmaceutics - Scientific guideline
- ICH Q8 (R2) Pharmaceutical development - Scientific guideline
- ICH Q9 Quality risk management - Scientific guideline
- ICH Q10 Pharmaceutical quality system - Scientific guideline
- ICH Q8, Q9 and Q10 - questions and answers - Scientific guideline
- Pharmaceutical development of medicines for paediatric use - Scientific guideline
- 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 - Scientific guideline