Today, the European Medicines Agency (EMA) has held an insightful webinar discussing the upcoming step 2 regarding the implementation of Clinical Data Publication activities under Policy 0070.
Key points presented during the webinar:
- All applications that receive a positive or negative CHMP opinion—including MAAs, extensions of indications, and line extensions—from Q2 2025 (provisionally April) onward will be included in this initiative, regardless of the status of the active substance.
- Withdrawn applications will be included.
- This step will exclude generics, hybrids, and biosimilars.
- For legacy procedures, Access-to-documents requests related to clinical data will trigger the Clinical Data Publication procedure.
At Asphalion, we can support your regulatory needs related to Policy 0070:
- Pre-submission interaction support.
- Redaction criteria definition.
- Management of Personal Protected Data (PPD) and Commercial Confidential Information (CCI).
- Preparation of Redaction Proposal Package and Final Package, along with eCTD publishing and submission.
Our experts are ready to help! Contact us to learn more about how we can assist you in being compliant with the upcoming implementation: [email protected]
Have a look at this timeline that ASPHALION experts have prepared for you to take into consideration the steps and timing regarding clinical data publication for new MAA. At the same time, You can also find out more about Asphalion’s expertise on Clinical Data Disclosure here.
