The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two. The two proposals, which each take the form of a draft directive and draft regulation, have now been sent to the European Parliament. The pharmacovigilance proposals had been piggybacked [read more…]
Archive for the ‘Pharmaceutical News’ Category
Disclosure by drug companies of results of clinical trials not necessary when they don’t lead to product development or commercialisation, but maybe useful for all parties involved.
Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research – even when product development is no longer being pursued, says a commentary co-authored by a leading drug researcher published online in Science Translational Medicine. In the commentary, titled [read more…]
Critics raise concerns over research, incentives of European pediatric exclusivity regulations
By Karyn Korieth Regulations introduced four years ago in Europe to encourage research into medicines for children have lead to important therapeutic breakthroughs for pediatric patients. Yet concerns also have been raised about how well the system works. The European law, similar to one passed in the United States, provides drug sponsors an additional six [read more…]
ENCePP publishes the ‘guide on methodological standards in pharmacoepidemiology’
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access to the main existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance. The aim of the ENCePP initiative is to [read more…]
The EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials
The European Commission says it accepts that the implementation of the directive has been deeply flawed and will legislate to fix the problems by October 2011. The Commission’s health directorate – which was handed control of EU pharmaceutical policy earlier this year describes the Clinical Trials Directive as “arguably the most criticised piece of legislation” the EU [read more…]
Innovation is in for EU’s Healthcare SystemEurope aim to increase jobs and growth through its “Europe 2020” strategy
By Peter O’Donnell It will come as little consolation to those already struggling to keep up with change to learn that more change is already on the way. Innovation is in, in Europe—again. And not just in the recast of the EU’s clinical trials rules currently brewing within the bureaucrats’ offices in Brussels. The entire [read more…]