The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for 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.
- ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors - Scientific guideline
- ICH Considerations: general principles to address virus and vector shedding - Scientific guideline
- ICH Considerations: oncolytic viruses - Scientific guideline
- ICH Quality Implementation Working Group: points to consider for ICH Q8/Q9/Q10 guidelines - Scientific guideline