EMEA-EFPIA Information Day 2009

February 26, 2009

Company News Release

The importance of dialogue in a challenging business environment

London, 24 February 2009: EMEA, the European Medicines Agency, the body responsible for the evaluation and supervision of medicines for human use in Europe, today played host to EFPIA, the voice of the research-based pharmaceutical industry in Europe, for their 14th joint annual Information Day. The event gathered over 100 people from industry to meet with regulators in an exchange of views and review of performance.

Thomas Lönngren, Executive Director of EMEA opened the meeting emphasizing the value of such a dialogue in a time of increasing globalization and a rapidly changing regulatory environment. It was important to provide robust scientific assessment of the highest quality, but to do so in a cost-effective manner. For EFPIA, Director General Brian Ager commented “The need for symbiosis between industry and regulators is ever more acute; pipeline productivity is of concern to all, and pressure on payers is increasing; it is clear we need to work together to ensure we expedite efficiency.”

The format of the EMEA–EFPIA Information Day allows for formal feedback on a series of mutually agreed performance indicators, allowing for active debate on areas for improvement. It also permits an industry insight into the Agency’s work plan and workload in the medium term.  The value of this ongoing discussion and the form it takes are of paramount importance to both bodies.

Amongst a number of issues addressed, the industry has concerns that a non-pragmatic approach to the paediatric legislation could lead to delays in adult medicines, something that was never envisaged. There was a consensus that the increasing number of committees involved in the authorization phases, including the pre- and post-phases, meant that coordination of dialogue with the various committees were a growing challenge.

Meanwhile the Agency pressed industry on the need to adopt standardized electronic submissions, and emphasizing that non-standard and paper-based submissions could not be prioritized. The Agency aims to migrate all new centralized product applications in the new format of e-CTD by 2012.

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