Pharmaceutical News

  The final version of EMA’s Module IV, regarding Pharmacovigilance Audits, came into effect 13 December 2012. There were several relevant changes to the draft version and we have listed them below: IV.B.2. It is no longer stipulated that the risk assessment for the strategic, tactical and operational planning should be performed by the auditors. [...]

The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years. The study finds that out-of-pocket costs to bring a new medicine to market have increased over this period by 600%. But success rates from proof of concept to registration have decreased at least twofold since [...]

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 the entire product development and commercialization more and more closely and there is little doubt that a share of Healthcare [...]

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 in Europe and especially in the UK. Each of these stakeholders have different priorities and interests: the Government needs primarily [...]