New Swiss requirements on submissions for generics and products with known APIs get industry thumbs up
This article was originally published in SRA
Recently implemented Swiss rules relating to marketing submissions for generics and products with known active pharmaceutical ingredients make the application process clearer and enable regulatory timeframes to be maintained.
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International Conference on Harmonisation technical working groups will now be expanded to allow active participation by experts from qualifying members of the Global Cooperation Group1. This was a key development of the ICH steering committee's meeting in Fukuoka, Japan, which took place from 6-11 November and marked the 20th anniversary of the ICH.
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