EMEA "An Undoubted Success," Says GW Chief

In its first year, the European Medicines Evaluation Agency has been an undoubted success, says Sir Richard Sykes, deputy chairman and chief executive of Glaxo Wellcome. It has gained the confidence of both the industry and the national agencies and has shown ability to achieve scientific goals in the face of budgetary restraint, he told the Third Annual Conference of Medicines Agencies, organized by the IDRAC division of IMS International, in London last week.

Competitive forces will become strong, Sir Richard forecast, as companies can still choose the national approval route until end-1997 except for biotechnology products. Competition will also exist in the centralized procedure, putting pressure on popular agencies that could lead to companies not always getting their first choice of rapporteur. Competition will raise standards of assessment and times, and companies will demand performance measures to be applied to the regulatory agencies, not only in Europe but also internationally.

Rigidity v Flexibility Sir Richard noted the need to balance high standards with flexibility in the application of approval procedures to account for differing medical practices. He called for a more pragmatic attititude towards the wording of the Summary of Product Characteristics, where a too-rigid approach could simply reflect the lowest common denominator of one country.