New! Clinical Data Publication (Policy 0070) 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
May 19, 2023

The EMA has recently announced their decision to restart the Clinical Data Publication- Policy 0070- activities (beyond COVID-19 medicines) 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.

and 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 and learn how Asphalion can help you!

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | Symposium AEFI 2024

¡Mañana arranca el 42º Symposium de AEFI! No olvidéis visitarnos en la mesa 6 para conocer de todos los servicios que ofrecemos. Os recordamos los

EVENT | RAPS Euroconvergence

Dates: May 6-8 | Berlin Congress Centre Day 1 at RAPS! ASPHALION’s team is in Berlin!! Come by booth B2 to get to know us

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting