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EHA at ICH meeting: Excessive bureaucracy harms patient safety and innovation
To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).
Read moreRevising the ICH Guidelines on Clinical Trials
The EHA delegation to the ICH meeting: from left to right, Professors Christian Gisselbrecht, Steven Le Gouill and Martin Dreyling. Clinical trials and drug development have become more complex over the years.
Read moreThe European Parliament adopts the Regulation on Substances of Human Origins (SoHO)
On April 24, the European Parliament gave its final endorsement to the regulation on Substances of Human Origin (SoHO).
Read moreRevision of the EU’s pharmaceutical legislation
Background on the reformIn April 2023, the European Commission (EC) published two proposals to revise the existing (and outdated) pharmaceutical legislation. This includes legislation on medicines for children and rare diseases.
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