Anti-bribery legislation hits statute book in UK
This article was originally published in RAJ Devices
The UK Bribery Bill was granted Royal Assent on 8 April and is now official law1,2. The legislation applies to all companies, including drug and medical device entities.
You may also be interested in...
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.
Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.
The International Council for Harmonisation is making big changes to its E19 guideline that proposes taking a targeted approach to safety data collection in some late-stage clinical trials. The draft guideline, which is largely similar to the US guideline on this topic, drew varied comments from stakeholders, including those from the EU.