The European Medicines Agency publishes the consideration documents 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).
Consideration documents are documents developed by discussion groups such as the Gene Therapy Discussion Group that report specific scientific considerations. They do not require the formal ICH approval procedure, but do require discussion and endorsement by the ICH Steering Committee.
If you have comments on a document that 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.
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