Use Of Real-World Data Hindered By Different Regulator Requirements

Real-world data is increasingly being accepted by medicines agencies to support their regulatory decisions, whether on initial marketing authorizations or for post-marketing surveillance purposes. However, there are challenges to overcome, not least disparities between the requirements of the EU and US regulators, according to the European pharmaceutical industry federation, EFPIA.

These conclusions are contained in a report called Evidence Mix, which is based on a survey of EFPIA member companies in the context of the European Commission’s planned changes to...