Stakeholders think parallel scientific advice is unlikely to result in true harmonization of data requirements from regulatory and health technology assessment bodies across Europe. However, EMA and reimbursement authorities are committing to more upfront discussion with companies to better inform development programs for both approval and reimbursement purposes.

At a workshop in November, stakeholders from EMA, industry and health technology assessment (HTA) agencies made clear that regulators and tech assessment bodies have different objectives when analyzing data.