Why have targets for the review process? An individual viewpoint

With the current complexities in Europe, performance targets are essential to drive worldwide competitiveness of the regulatory system. Performance targets provide direction and focus by binding the stakeholders together with a common purpose. These targets should be aligned with the strategic objective and underpinned by performance measures.

There are five main processes in Europe where target setting and performance measurement are vital: provision of scientific advice, Centralised and Mutual Recognition Procedures, post-approval variations and pharmacovigilance. Shorter cycle times are particularly needed for the first four of these processes.

Both the Centralised and the Mutual Recognition Procedures are complex processes with multiple owners that are rate-limiting on the launch of a product. A target of not more than 9 months for the cycle time from submission to launch in 15 markets is proposed for each procedure.

Such challenging stretch goals for both the EU regulatory processes and the parties involved in those processes underline the need for Europe to remain competitive in its approval times.

Agency performances are becoming more directly comparable. Benchmarking information makes the time to availability of new medicines to patients more transparent.