European Risk Management Strategy (ERMS)

The European Risk Management Strategy (ERMS) aims to provide for a more proactive conduct of pharmacovigilance by putting in place measures that allow for the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle.

No effective medicine is without risk and the benefits of a medicinal product always need to be weighed up against its risks. The challenge for regulators is to find the right balance between timely availability of new medicines and the fact that knowledge on the safety profile is limited at the time of marketing authorisation.

For more information, see:

• European Risk Management Strategy Facilitation Group

European Risk Management Strategy: 2008-2009 work programme adopted

Reference Number: EMEA/564868/2007

Implementation of the action plan to further progress the european risk management strategy: rolling two-year work programme (2008-2009)

AdoptedReference Number: EMEA/280089/2007

Public Status Report on the Implementation of the European Risk Management Strategy (Reporting Period Mid 2005 – Mid 2007)

Reference Number: EMEA/168954/2007

European Risk Management Strategy: Achievements to date

Reference Number: EMEA/308167/2007

European Risk Management Strategy (ERMS) Facilitation Group

Reference Number: EMEA/424988/2005

Implementation of the action plan to further progress the european risk management strategy: rolling two-year work programme (mid 2005-mid 2007)

AdoptedReference Number: EMEA/372687/2005

European Risk Management Strategy: Progress to date and next steps

Reference Number: EMEA/136253/2005

Action plan to further progress the european risk management strategy

AdoptedReference Number: EMEA/115906/2005/Final