Pharmaceutical News and Updates

Good Pharmacovigilance Practice (GVP)

The new Pharmacovigilance Legislation (GVP modules) in Europe is an attempt to harmonise and rationalise a complex set of regulations, which are out of date and purpose. The main objective is to define clear roles and responsibilities and also ensure a better interaction between the Industry and regulatory assessors. Regulators…

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 the entire product development and commercialization more and more closely and there is little doubt…

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…