Quality: active substance
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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.
Guidelines
- Active substance master file procedure
- Chemistry of active substances (chemistry of new active substances)
- ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline
- Investigation of chiral active substances
- Summary of requirements for active substances in the quality part of the dossier
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline
Reflection papers
- 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
Questions and answers
- Quality Working Party questions and answers on API mix
- Questions and Answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation
Recommendation documents