Adapting registries

After years of asking drug companies to collect postmarket safety data via registries, EMA has come to the conclusion that duplication of efforts among companies and the resulting differences in standards are limiting the usefulness of the data. The agency's proposed solution is to develop standards for the design and operation of registries, and to encourage the creation and use of disease registries rather than product-specific registries.

Doing so should both allow better comparison of data on different products, and enable registries to be used in the agency's adaptive pathways program...