Commission consults on GMP rules for active substances under EU falsified medicines legislation
This article was originally published in SRA
The European Commission is seeking feedback on its plan to extend the scope of the medicines Directive 2003/94/EC on good manufacturing practices so that its provisions will also apply to the manufacturing of active substances1,2.
You may also be interested in...
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
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.