ICH: quality

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The European Medicines Agency publishes guidelines on the quality of medicines that are harmonised between Europe, Japan and the United States of America by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.


Analytical validation


Regulatory acceptance

Quality of biotechnological products


Good manufacturing practice

Pharmaceutical development


Lifecycle management


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