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