Regulator's plans require automation

The European Medicines Agency says it plans to do something about the high attrition rate of drugs in development. And without saying so explicitly, it implies an increased role for automation both within its own organization and among its industry constituents.

In its Road Map to 2015 issued last week, the EMA says it will improve its model for assessing the benefits and risks of medicines, along with the quality, scientific, and regulatory consistency of the medicine-review process. The agency says that the road map builds on its earlier map, which extended to this year, but also takes account of the "changing environment" it anticipates over the next five years, says ePT.

Additional priorities involve deeper assessment of the benefits and risks of a drug following it approval via "novel pharmacovigilance methods and risk-minimization tools." Drug developers that have software tools in place for collecting, measuring and reporting process and outcomes data will likely have an easier time with the agency's transition.

The roadmap is expected to be finalized by end of year.

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