EMA narrowly defines 'commercially confidential information' amid industry concern
This article was originally published in Scrip
The European Medicines Agency has finalised its much-awaited guideline on what constitutes "commercially confidential information" and "protected personal data" in a drug marketing authorisation application. Despite reservations by the pharmaceutical industry, non-clinical (ie preclinical) data has not been categorised as commercially confidential, which means it can be made available to the public.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-two guidance documents have been posted on the tracker since its last update.
Italian medicines agency chief Nicola Magrini recounts the problems AIFA faced and the lessons it learned through its work at the height of the coronavirus outbreak in Italy.
EU guidance offers high-level recommendations on the steps that clinical trial sponsors should take to assess the impact of COVID-19 on the quality and reliability of data being generated in ongoing studies. Early scientific advice is recommended if changes must be made to existing protocols or data analysis plans.