Quality: pharmaceutical development
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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