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 [read more…]
Archive for the ‘Pharmaceutical News’ Category
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 NHS medicines. For this purpose, a branded NHS medicine is defined as a human pharmaceutical product for which a marketing [read more…]
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 in Europe and especially in the UK. Each of these stakeholders have different priorities and interests: the Government needs primarily [read more…]
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 as a starting point. The main difference probably lies in the growing demand for Companies to evaluate more deeply the benefit/risk profile [read more…]
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 paper. The electronic submission and [read more…]
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.