EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a webinar held on May 16, 2023.
All Marketing Authorization Holders who submit packages to EMA should immediately implement document anonymization processes.
EMA Policy 0070, which was originally implemented on January 1, 2015, has been around for almost a decade. The suspension of EMA Policy 0070 in December 2018 was due to the COVID Pandemic. But now, EMA Policy 0070 will be reactivated.
What is the scope of this document?
Sponsors should be aware that EMA Policy 0070 has remained largely unchanged, but some changes have been made to the procedures.
The scope of relaunch includes
- New Active Substances (NAS), September 2023
- Negative and withdrawn goods
- COVID-19 (and other Public Health Emergency Clinical Data)
- MAHs affected will receive detailed, specific letters inviting them to request the packages
- Meetings to discuss the scope of publication, anonymization strategy, and commercially sensitive information CCI strategy.
Changes to improve efficiency and continue collaboration with Health Canada.
What’s new in EMA Policy 0070 relaunch?
The EMA Policy 0070 Team will work closely with the Clinical Trial Information System team (CTIS) to ensure that both efforts are uniform and consistent. The EMA wants to complete package preparation as soon as possible – as soon as the sponsors receive a letter of invitation from EMA in relation to EMA Policy 0070.
Pre-submission meetings will be tailored to each product. The scope of publication as well as anonymization will be discussed at this meeting.
The EMA will develop new templates for anonymization reports in collaboration with Health Canada. It will also draft a list for the marketing authorization holder of the documents that are eligible for anonymization.
Re-launching EMA Policy 0070 enhances transparency and public trust in clinical research by allowing researchers and healthcare professionals access to clinical data. This policy will enhance the scientific integrity and safety of healthcare decisions by ensuring efficient and safe clinical trials.
Key Points from Webinar
- Any submission getting decision from September 2023 would be eligible to submit the anonymized package as per Policy 0070.
- Submission done after suspension of Policy 0070 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 is 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 the public and will continue to be published under Policy 0070 even if a decision on it is made before September 2023.
- Timelines have been revised from 60 days to 120 days for publishing the anonymized package from the date of CHMP opinion on initial marketing authorization applications.
Important Links:
[1] https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation
[2] https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication
[3] https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html
[4] Clinical Data Publication (Policy 0070) re-launch – EMA webinar | European Medicines Agency (europa.eu)
By Parveen Kumar – Head of Data Transparency & Product Owner, GENINVO
