This ICH Reflection Paper was endorsed by the Assembly in June 2019.
This Paper proposes a strategic approach to international harmonization of technical scientific requirements for pharmacoepidemiological study data submitted to regulatory agencies. In recent years, the sophistication of pharmacoepidemiological studies conducted in various countries worldwide has advanced dramatically alongside more active use of Real-World Data. Many regulatory agencies and industries are now conducting epidemiological safety assessments based on data gathered during the post-marketing stage. The goal is to harmonise the technical scientific requirements related to pharmacoepidemiological studies submitted to regulatory agencies. Harmonisation in this area facilitates utilization of Real-World Data and promote a globally-harmonised approach in post-marketing safety-related regulatory actions based on the most current scientific evidence.
This Paper furthermore describes the remit of the Pharmacoepidemiology Discussion Group (PEpiDG), which will serve for a two-year period to support the advancement of harmonisation of scientific and technical requirements related to pharmacoepidemiological studies.
