Monday, December 23, 2013
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.