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.

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)
• 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"

Reflection papers

• Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances
• 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

• Recommendation on the assessment of the quality of medicinal products containing existing/known active substances