Quality guidelines: active substance
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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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"