Archive for 2014

Implementation of Clinical Trials Regulation: State of play

Monday, November 24th, 2014 in News

The Clinical Trials Regulation (CTR, Regulation (EU) 536/2014) has entered into force on 16 June 2014. It will be applicable once the EU Clinical Trials Portal and the Database, developed by EMA, are fully operational. This is likely to be the case in mid 2016. a) Access to the database ... read more...

French plans to cut spending through off-label medicines jeopardizes patient safety and challenges EU regulatory standards

Friday, July 11th, 2014 in News Press Releases

July 11, 2014, Brussels - The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is very concerned about legislative developments on the use of off-label medicines in France. This week, the lower house of the French Parliament, the Assemblée nationale, voted on a draft law which would broaden the use of off-label ... read more...

French Sunshine Act: French Ministry of Health launches official website

Friday, July 11th, 2014 in News

The French Ministry of Health issued a decree relating to the establishment and the running of a website which shall make information about the cooperation between healthcare companies and healthcare professionals publicly available. At the end of 2011 a new French law to ensure transparency on decision-making within the healthcare ... read more...