CMR International R&D Briefing 31 – Profile of performance: Review times – is there still room for improvement?

Key messages:

  • Performance improvement initiatives established by regulatory authorities in the early 1990s have resulted in the reduction, and in recent years, stabilisation of approval times in several markets.
  • The European licensing systems continue to evolve andare currently subject to an operational review. Variations are evident between the two licensing procedures, particularly in terms of overall performance.
  • Comparisons of approval times in Europe and the USA are often sought as these allow the investigation of the underlying review processes which is important in terms of patient access to new medicines. There appears to be concordance of overall review time between Europe and the USA, however the majority of dossiers are not submitted simultaneously to both markets.