HMA makes public rejected EU drug applications
This article was originally published in SRA
The EU Heads of Medicines Agencies has published a template for issuing public assessment reports on drug applications that are refused marketing authorization under the EU's mutual recognition and decentralized procedures1.
You may also be interested in...
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.
Existing importers and manufacturers of certain medical devices can continue marketing their products for six months or until the Indian medtech regulator makes a final decision on their pending licensing applications.
Differences between how Australia and the EU define “central circulatory system” has resulted in different risk classification levels being assigned to some devices in the two jurisdictions.