by Nick Paul Taylor on
Germany’s healthcare cost watchdog is continuing to push back against the European Medicines Agency’s (EMA) plans to accelerate the approval of new medicines. The German institute worries fast-track drug approvals based on limited clinical trial data or real-world evidence will become the norm—and that this will undermine attempts to gauge the true safety and efficacy of medicines.
EMA has spent the past few years developing and piloting a scheme that would allow companies to win approval in a restricted patient population on the basis of limited data, before going on to generate additional clinical real-world evidence to support wider use of the drug. The regulator rejected most applications to join the pilot scheme—bluebird bio and Immunocore were among the successful companies—but Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) nonetheless fears its ideas will creep into standard practice.
Read more / Source: http://www.fiercebiotech.com/biotech/national-agency-pushback-against-ema-fast-track-continues