The European Medicines Agency's scientific guidelines on Quality by Design 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
- ICH Q8 (R2) Pharmaceutical development
- ICH Q9 Quality risk management
- ICH Q10 Pharmaceutical quality system
- ICH guideline Q13 on continuous manufacturing of drug substances and drug products
- ICH Q8, Q9 and Q10 - questions and answers
- ICH guideline Q13 on continuous manufacturing of drug substances and drug products
- Real time release testing
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline