EMA Finds Patient Involvement Beneficial

On May 8, 2017, the European Medicines Agency (EMA) released a report on its pilot project to involve patients in the benefit-risk assessment of medicines at Committee for Medicinal Products for Human Use (CHMP) meetings. The agency concluded that patient involvement was beneficial and should continue.

The pilot project, which ran from September 2014 to December 2016, involved patients participating in discussions at the CHMP. Six medicines were evaluated in the pilot project. Patient input was considered when CHMP was evaluating authorization for new drugs; the maintenance, suspension, or revocation of an existing authorized drug; or restrictions on indications of authorized drugs.

Due to the positive outcome of the pilot project, CHMP decided to develop additional ways patients can be involved in CHMP discussions, such as teleconferences or organized written consultations. Patients also assist EMA in other ways, including as members of the various agency committees, as experts in scientific advice procedures and advisory groups, in reviewing information documents, and as members of the Patients’ and Consumers Working Party.

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