Pharmaceutical News and Updates
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From Drug Manufacturers to value-added Providers
Countries have being implementing cost containment measures since at least 2000. What is ‘new’, since the ‘financial crisis’ of 2008, is the pace and the severity with which budget controls are applied. Politicians are influencing…
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The new Price and Reimbursement for Pharmaceutical Products suggests big changes, but is still in the making
The Pharmaceutical Price Regulation Scheme (PPRS) is the current UK-wide price regulation scheme for branded prescription medicines supplied to the NHS. It applies across the four nations of the UK. The PPRS covers all branded…
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Real World Data
By Simon Ruini Since 2007, all major stakeholders involved in the development, marketing, authorisation and use of pharmaceutical products have felt the need for a change of their interaction and approach to the current system…
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From PSUR to PBRER, more focus on Benefit/Risk
The EMA has invited comments on the new ICH-E2C guideline on periodic safety reporting. The periodic safety report on marketed medicinal products maintains the old reporting timeframe, with the IBD (international Birth Date) to be taken…
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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,…
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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…
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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…
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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…
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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…
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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…