Pharmaceutical News and Updates

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…

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…

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…

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…