EMA Policy 0070 will be relaunched effective September 2023, as announced by the European Medicines Agency (EMA) during a webinar on Tuesday, May 16, 2023.
Now, all Marketing Authorization Holders (MAHs) submitting packages to the EMA must immediately plan document anonymization procedures accordingly.
EMA Policy 0070 has been around for almost a decade, originally coming into effect January 1, 2015. Its suspension in December 2018 as part of the Business Continuity Plan was lengthened due in part to the COVID pandemic, but now EMA Policy 0070 is getting a reboot.
What’s in scope?
Overall, the aims of EMA Policy 0070 will remain the same, but there are some procedural updates that sponsors should be aware of.
The scope of the relaunch includes:
- New Active Substances (NAS) from September 2023 CHMP
- Negative and withdrawn products
- COVID-19 and other public health emergency clinical data
- Detailed, specific invitation letters will be sent to impacted MAHs to request packages
- Pre-submission meetings to discuss scope of publication, anonymization approach, and commercially confidential information (CCI) strategy
- Changes to improve efficiency and continue collaborative alignment with Health Canada
The EMA Policy 0070 team will be working closely with the Clinical Trial Information System (CTIS) team to ensure both efforts are consistent and uniform. The EMA is aiming for package preparation to be completed as early as possible – as soon as sponsors receive an invitation letter from the EMA regarding EMA Policy 0070.
There will be targeted pre-submissions meetings specific to the individual product. This meeting will discuss the scope of publication and anonymization approach.
New anonymization report templates will be developed jointly with Health Canada, and the EMA will draft a list of documents in-scope for anonymization and send to the Marketing Authorization Holder for agreement.
The EMA Policy 0070 re-launch enhances the transparency in conducting clinical research and promoting public trust by providing access to clinical data to researchers and healthcare professionals. This policy will improve the scientific integrity of clinical trials and ensure efficient and safe healthcare decision-making.
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