German body calls for pause in European plan for fast track drug approval

BMJ 2016; 354 doi: (Published 16 August 2016) Cite this as: BMJ 2016;354:i4479
  1. Nigel Hawkes
  1. London

Plans by the European Medicines Agency to expand its fast track approach to approving new drugs have provoked a tough response from an influential German body, the Institute for Quality and Efficiency in Healthcare (IQWiG).

In a commentary published on 12 August IQWiG said that the plan was vague and failed to provide sufficient reassurance that drugs approved under the fast track approach would be safe and effective.1 It called for the scheme to be paused.

Earlier this month the EMA published the final report on its pilot scheme, claiming that its fast track approach would provide important benefits as long as the right drugs were chosen and all interested parties were consulted.2 But …

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