Pharmaceutical News and Updates

Simplified filing and review of studies in Austria

By Simon Ruini, London The Ethics Committee of the Medical University of Vienna has approved a new submission method of clinical research projects and also their assessment is now available online. Unlike in the past, the submission and evaluation of clinical research projects and studies is now possible entirely without…

European Medicines Agency releases good pharmacovigilance practice modules for public consultation

The European Medicines Agency has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012. Each of the seven modules released today covers one major process in the safety monitoring of medicines.

EU publishes new drafts of patient information and pharmacovigilance proposals

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…

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…

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…

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…