Policy 0070- Clinical Data Publication for new MAA | Re-launch

The scope of the policy relates to clinical data, composed of clinical reports and individual patient data (IPD), submitted under the centralised marketing authorisation procedure after the effective date (see chapter 4.3. for further information), either using the common technical document (CTD) format or another format

The scope of the policy relates to clinical data, composed of clinical reports and individual patient data (IPD), submitted under the centralised marketing authorisation procedure after the effective date (see chapter 4.3. for further information), either using the common technical document (CTD) format or another format

September 29, 2023

From September 2023, the EMA is progressively restarting the activities related to Policy 0070 for centrally authorised medicinal products for human use.

Have a look at this Infographic that Asphalion experts have prepared for you to take into consideration the steps and timing regarding clinical data publication for new MAA.

Reach out to us now at [email protected] to be ready for policy 0070 and learn how Asphalion can help you!

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