European Focus on ADRS

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

In 2002 the public health importance of adverse drug reactions was recognised by the European High-Level Group on Innovation and Provision of Medicines (the so-called ‘G10 group’) comprising health ministers, patient representatives and industry leaders.


EUROPEAN FOCUS ON ADRS

In 2002 the public health importance of adverse drug reactions was recognised by the European High-Level Group on Innovation and Provision of Medicines (the so-called ‘G10 group’) comprising health ministers, patient representatives and industry leaders. The G10 report recommended that ‘industry and national regula-tory authorities should undertake regular monitoring to ensure that medicines once authorised meet the required standards of safety systems for post marketing surveillance should be optimised to ensure co-ordinated processes are in place to gather data’ (European Commission G10 Medicines, 7 May 2002).

Following publication of the G10 report, in 2002 the heads of the European national medicines agen-cies set up an ad hoc Working Group on estab-lishing a Risk Management Strategy (European Risk Management Strategy (ERMS) Working Group) to take stock of the current status of pharmacovigilance in Europe and explore how it could be strengthened. The EMEA had at that time presented proposals for a risk management strategy concentrating on centrally authorised products, and it was accepted that the future strategy should be applicable to all medicines on the European market, including those authorised nationally and by mutual recognition. An initial report of the ERMS Working Group published in January 2003 set out priorities for action and subsequently led to a programme of work published in May 2005 encompassing a range of operational improvements.

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