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News about GMP/cGMP

EMA: Roadmap to 2015

The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010.

 

European and international partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public are invited to make their views known on the Agency’s future strategic vision, set out in the document ‘The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health’.

Building on the achievements made by the previous Road Map initiative between 2005 to 2010, the focus of the new Road Map to 2015 is on continuous high-quality delivery of the Agency’s core business in an increasingly complex regulatory and scientific environment. In addition, the document proposes three priority areas for future actions to strengthen the Agency’s role in protecting and promoting human and animal health in the European Union. These include:

• Addressing public health needs by: stimulating research and medicines development in areas of unmet medical needs or for neglected and rare diseases; facilitating new and innovative approaches to the development of medicines; implementing effective preparedness plans to deal with public health threats.

• Facilitating access to medicines by: addressing the high attrition rate during the development process of medicines; improving the Agency’s model for the assessment of benefits and risks of medicines; improving the quality and scientific and regulatory consistency of the medicines review process.

• Optimising the safe use of medicines by: strengthening the evidence base on the benefits and risks of a medicine following its authorisation; applying novel pharmacovigilance methodologies and risk minimisation tools; by taking patient experience into account for improved decision-making; becoming a reference point on information about medicines evaluated by the Agency.

Aiming for a wide consensus amongst its partners and stakeholders, the Agency will hold a number of workshops and face-to-face discussions as part of the public consultation process. The Agency will provide regular updates on the progress of its Road Map to 2015 until its final adoption through its Management Board, expected for December 2010.

Outcome:

Comments should be sent using the Agency’s comments form by 30 April 2010 to mailto:roadmap@ema.europa.eu.

Links:

The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health

The Agency’s comments form

Source:

EMA:Press release Roadmap to 2015

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