An 18-month feasibility pilot initiative was conducted from June 2017-December 2018 under the framework of the confidentiality arrangements established between the European Commission, the EMA, the U.S. FDA and PMDA. The main objectives of the initiative were to evaluate the timing of GCP inspections and exchange of information related to GCP issues for common marketing submissions among the three agencies as well as identify best practices in GCP process and procedure.
Its results are available in the report below.
EMA-FDA and PMDA GCP Pilot Collaboration Report (June 2017-December 2018)
Based on the outcomes of this pilot initiative, EMA and FDA agreed to add PMDA as an official member of the GCP initiative and to continue this activity.