- Any submission getting decision from September 2023 would be eligible to submit the anonymized package as per Policy 0070.
- Submission done during suspension of Policy 0070 i.e. after Brexit and before September 2023, would not need to be published immediately but it would be done based on request and proper planning to avoid burden on Sponsors and EMA.
- Invitation letters will be sent if your product is in scope.
- Emphasis on 1) early preparation of packages for submission – prior to Opinion and 2) Complete QC check prior to submission – all documents present.
- EMA worked collaboratively with Health Canada to create a common template for anonymization report.
- EMA Policy 0070 Team will work closely with the Clinical Trial Information System team (CTIS) to ensure that both efforts are uniform and consistent. However, anything redacted as CCI for CTIS does not make it eligible for CCI for Policy 0070. Following were the major reasons of rejection of CCI and shall be considered for future:
- Information already in public domain.
- Specific details shall be redacted as CCI in place of complete paragraphs.
- Lack of Proper justification for CCI to explain how it impacts economic benefit of the sponsor.
- Covid-19 projects are still of interest to public and will continue to be published under Policy 0070 even if decision on it is made before September 2023.
- Timelines have revised from 60 days to 120 days for publishing the anonymized package from the date of CHMP opinion on initial marketing authorization applications.
Please add if I have missed any of the important points.
