European Notebook: EMA’s 2016 Work Agenda; Clinical Trial Rule Delay; Ireland Benefits From Pfizer Merger
The European Medicines Agency wants to accelerate clinical development plans with new processes and procedures in 2016 and companies must disclose payments to providers starting mid-year; Ireland and Switzerland look set to grapple with high drug prices, and France's industry wants to reverse the erosion of jobs.
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EMA official gives perspectives on how PRIME and adaptive pathways compare, and how they fit with other programs such as conditional authorization.
EMA will reinforce its role as a global reference authority and help build regulatory capacity in less experienced countries, Guido Rasi says in outlining his five-year priorities for the agency. He hopes regulatory efficiencies might contribute to lower drug prices.