Future Challenges and Conclusions

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Chapter: Pharmacovigilance: Regulatory Pharmacovigilance in the EU

The medicines legislation has recently been reviewed by the European Commission with the resultant changes having come fully into force in November 2005.


The medicines legislation has recently been reviewed by the European Commission with the resultant changes having come fully into force in November 2005. Although there is no fundamental change to the basic system, many elements have been re-enforced or newly introduced, with the aim to improve pharmacovigilance and to meet the higher expectations of EU citizens. Such expectations also lie in establishing mechanisms for direct reporting of adverse experiences by consumers, and related initiatives have been started at the level of some Member States and through dialogue at EU level. Another important challenge results from the EU enlargement in 2004 and 2007, involving Central and Eastern European countries. Steps have already been taken since 1999 to integrate the new countries in drug regulation and pharmacovigilance activities through an initiative known as the Pan-European Regulatory Forum (PERF). In this context, it is particularly impor-tant to have in place agreed standards for the conduct of pharmacovigilance for all the parties involved. The PhVWP is currently developing such standards for regulators through an initiative known as good phar-macovigilance practice (GVP). Particular efforts are also being put into further development of the elec-tronic information network through the EudraVigilance project.

One important limitation of all current pharmacovig-ilance systems is the difficulty in measuring the effects of the actions taken. It will be particularly important for EU competent authorities to address this using the available electronic epidemiological databases. Expec-tations of consumers in respect of drug safety have increased considerably in recent years (EMEA/CHMP Working Group with Patient Organisations, 2005) and are likely to continue to do so. To meet these expecta-tions, processes will need to become even more trans-parent and to be demonstrably effective. Communica-tion tools also need to be improved, and it will be impor-tant that both competent authorities and pharmaceutical companies ensure full compliance with their pharma-covigilance obligations.


The system of pharmacovigilance established in the EU aims to promote the safe use of medicines in clinical use thereby protecting public health. During the 1990s, existing pharmacovigilance systems in Member States have been brought together to form an EU-wide system that currently, after the EU Enlargement in 2004, covers a population of more than 450 million people. The main challenges of the future include further EU enlarge-ment and the increasing expectations of consumers. To meet these challenges, and to efficiently add further value in the protection of public health, the system is continuing to evolve, particularly in response to scien-tific progress and technological developments. Optimal use of the best evidence and expertise for decisions will be essential to conduct proactive pharmacovigilance for medicines in any phase of their product life.

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