Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS
Recommendation

10/11 February 2026
Risk analysis, preventive measures and incident management
At the beginning of October, we reported on important changes for entries in the EudraGMDP Database.
To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The webinar covered the following topics:
- Integration of EudraGMDP and OMS – implications for industry users;
- OMS services and activities;
- OMS change request process;
- customer service (EMA Service Desk)
- data quality management.
The EMA has now published a document entitled Questions and answers from the webinar for industry on integration of EudraGMDP and OMS.
The 13-page PDF document contains 87 questions raised during that webinar and the corresponding answers.
The slides shown during the webinar and the recording of the event were already published on the EMA website in October.
Related GMP News
28.01.2026What is the Procedure for GMP Inspections (EU GMP inspections and FDA Inspections)?
21.01.2026FDA Warning Letter highlights critical Failures in Supplier and Quality Oversight
19.01.2026GMP Auditor Association Developments September through December 2025
03.12.2025What are GMP Audits and what Qualifications do GMP Auditors need to have?
19.11.2025Root Cause Analysis and CAPA - Why FDA Keeps Calling Them Out
22.10.2025EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated


