Introduction and Historical Perspective

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Chapter: Pharmacovigilance: Regulatory Pharmacovigilance in the EU

Modern drug regulation in Europe began in the 1960s in the wake of the occurrence of several thousand cases (most of them in Europe) of phocomelia, a congenital limb abnormality, which was caused by exposure to thalidomide during pregnancy (Stephens and Brynner, 2001).


Regulatory Pharmacovigilance in the EU

INTRODUCTION AND HISTORICAL PERSPECTIVE

Modern drug regulation in Europe began in the 1960s in the wake of the occurrence of several thousand cases (most of them in Europe) of phocomelia, a congenital limb abnormality, which was caused by exposure to thalidomide during pregnancy (Stephens and Brynner, 2001). In response to this tragedy, spontaneous adverse drug reaction (ADR) reporting schemes were developed with the aim of providing signals of unexpected hazards. Also legislation was passed to provide regulatory controls on quality, safety and efficacy of medicines through systems of standards for development and manufacturing, autho-risation, pharmacovigilance and inspection. In the European Union (EU), the first Community Directive on medicines was enacted in 1965 (Council Directive 65/65/EEC) and laid down basic principles relating to these systems, which are still operational early in the third millennium. In particular, quality, safety and efficacy are the criteria through which medicines are regulated, and other factors, such as cost, are not taken into account in decisions relating to the granting of a marketing authorisation.

Despite the extensive requirements for evidence on quality, safety and efficacy which are necessary to gain a marketing authorisation, pharmacovigilance remains a high priority for regulatory authorities in the EU. Although the quality and efficacy of a medicine are generally well described at the time of autho-risation, conclusions on the adverse effect profiles of medicines from clinical trials are limited by the numbers and selectivity of patients included in such trials, their duration and the relatively controlled conditions under which they are conducted. Safety in practice can only be assessed after marketing, and it is well recognised that hazards may emerge at any time during the life of a product. Hence, there is a need to monitor continuously the safety of all marketed medicines indefinitely. The overall objec-tives of regulatory pharmacovigilance (Waller, Coul-son and Wood, 1996) are summarised in Table 14.1.


Spontaneous reporting schemes continue to underpin such monitoring throughout the EU and have proved successful in identifying many important safety issues. However, both false positives and false negatives have being the failure to identify the oculomucocuta-neous syndrome induced by practolol at an early stage (Felix, Ive and Dahl, 1974). Specific limitations of spontaneous reporting schemes include underreport-ing and uncertainty about causality and frequency. Thus, many other sources of information are also used. There is increasing emphasis on epidemiological stud-ies and the use of databases in the EU Member States such as the UK General Practice Research Database (Walley and Mantgani, 1997, see Chapter 27) and the Dutch PHARMO system (Herings, 1993) to evaluate the safety of marketed medicines.

During the early 1990s, closer co-operation between Member States developed as proposals for a more closely integrated regulatory system were formulated. Ultimately, this led in 1995 to the establishment of the European Agency for the Evaluation of Medici-nal Products (EMEA), since 2004 called the European Medicines Agency, and to a new regulatory system that includes procedures for a centralised authori-sation and multiple identical authorisations through a decentralised procedure and a mutual recognition procedure. These procedures have had a consider-able impact on the operation of pharmacovigilance in the EU. Although pharmacovigilance continues to be based on national systems, particularly in terms of data collection and expertise, there is central co-ordination through the EMEA and the Pharmacovigi-lance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP, previ-ously called CPMP). This involves agreed standards and procedures as well as systems for exchanging information and decision-making, which are described further below.

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