Regulatory Toxicology in the European Union
CHAPTER 4: Pharmacovigilance for Authorised Human Medicinal Products in the European Union
Published:21 Feb 2018
The medicines environment has changed substantially over the last 50 years, with increased globalisation moving away from dependency on the traditional markets of the USA, European Union and Japan. Products are now being introduced into different markets almost simultaneously. This means we need to be even more efficient in our collection and management of data about the benefit and risk of medicines throughout the product lifecycle. Systems and processes need to be robust and transparent to support the fundamentals of ensuring good quality specifications. Standardisation of the collection of data is important so that it can be applied anywhere. As of July 2012, new European Union Pharmacovigilance Legislation was introduced based on Regulation (EU) 1235/2010 and Directive 2010/84/EU. The aim is to collect the best evidence, which has to be supported by a more robust and transparent system with standardisation of data collection and greater emphasis on data quality. Regulatory decision making and enforcement have become more transparent with the creation of the Pharmacovigilance Risk Assessment Committee and greater release of documentation of activities, including access to clinical trial data on the European Medicines Agency website. There has been a great emphasis on signal detection from any source worldwide and a move from risk management to benefit risk management, with monitoring and assessment of effectiveness now part of pharmacovigilance.