UK rejects 30% of all minor variation applications
This article was originally published in SRA
Executive Summary
The UK Medicines and Healthcare products Regulatory Agency has rejected as many as around 30% of applications to make relatively minor changes to marketed drugs since the new Variations Regulation came into force in the European Union on 1 January 20101-3.
You may also be interested in...
Norway COVID-19 Vaccine Deaths Draw Global Attention
Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
COVID-19 Vaccine Dosing: Pharma Says Follow The Science As It Gathers Data
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.
India Permits Sale Of Some Devices Beyond Licensing Deadline
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: