Quality: active substance
The European Medicines Agency's scientific guidelines on the quality aspects of active substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Active substance master file procedure - Scientific guideline
- Chemistry of active substances (chemistry of new active substances) - Scientific guideline
- ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline
- Investigation of chiral active substances (human) - Scientific guideline
- Summary of requirements for active substances in the quality part of the dossier - Scientific guideline
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline
- Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Scientific guideline
- Use of cocrystals of active substances in medicinal products - Scientific guideline
Questions and answers
Recommendation documents