Policy 0070- Clinical Data Publication | 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
August 23, 2023

As EMA announced mid-June, the Clinical Data Publication activities -Policy 0070- are set to restart in September, 2023.

Policy 0070 on publication of clinical data for medicinal products for human use was initially implemented in 2016 with the objective to make clinical data publicly available. However, in December 2018, the Agency suspended the publication of clinical data as a result of the implementation of the third phase of EMA’s business continuity plan. During the COVID-19 pandemic, the EMA reactivated the publication of clinical data for COVID-19 treatments and vaccines as an exceptional measure to maximise the transparency on these medicines, in order to address the strong desire for information and to support global research.

From September 2023, the EMA will progressively restart the activities related to Policy 0070 for centrally authorised products for:

  • Non-COVID-19 medicines: initial MAAs for new active substances that receive a CHMP opinion in September 2023 and onwards.

 

Furthermore, it will continue with the publication of clinical data for:

  • COVID-19 medicines: MAAs, extensions of indication and line extension applications.

 

Reach out to us now at info@asphalion.com to be ready for policy 0070 and learn how Asphalion can help you!

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