The European Medicines Agency’s scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
The Agency strongly encourages applicants and marketing authorisation holders to follow these guidelines. Applicants need to justify deviations from guidelines fully in their applications at the time of submission. Before that, they should seek scientific advice, to discuss any proposed deviations during medicine development.
Quality guidelines are provided for:
- Active substance
- Specifications, analytical procedures and analytical validation
- Pharmaceutical development
- Quality by Design
- Specific types of products
- Post-approval change management protocols
For the quality guidelines on biological medicines and materials of animal and/or human origin, see Biologicals.
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