Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 

I am looking to confirm the post-study reporting requirements in the EU for a non-interventional study (therefore outside of the scope of the Clinical Trials Regulation). 

We terminated a patient registry study early as the marketing authorisation for the drug product was withdrawn due to commercial reasons only. 

As a result of withdrawing the marketing authorisation, our Annex II obligation to submit a CSR was removed. However, I think a CSR would still be required (but likely an abbreviated version as the study was cut short). 

I am aware of EMA's guideline on registry studies but it is not really answering my question on the reporting requirements once the study ends. 

I think this my be determined by national/local laws and guidelines in the EU countries where we had ethics approval for the registry study. In addition, I think the EU pharmacovigilance legislation will also apply here. However we are in the grey area as there is no longer a marketing authorisation. 

Appreciate any feedback people may have from experience.

Hello,

My personal experience with some terminated drug development programs is that companies submitted shorter version of CSR. Generally, the authorities are looking to have CSR if there was a clinical trial conducted in the country. 

Have a good week.
Olga

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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
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Original Message:
Sent: 20-Jan-2023 06:21
From: Anonymous Member
Subject: EU Guidance Post Authorisation Efficacy Study_Patient Registry Study_non-interventional study

This message was posted by a user wishing to remain anonymous

Hi all,

I am looking to confirm the post-study reporting requirements in the EU for a non-interventional study (therefore outside of the scope of the Clinical Trials Regulation).

We terminated a patient registry study early as the marketing authorisation for the drug product was withdrawn due to commercial reasons only.

As a result of withdrawing the marketing authorisation, our Annex II obligation to submit a CSR was removed. However, I think a CSR would still be required (but likely an abbreviated version as the study was cut short).

I am aware of EMA's guideline on registry studies but it is not really answering my question on the reporting requirements once the study ends.

I think this my be determined by national/local laws and guidelines in the EU countries where we had ethics approval for the registry study. In addition, I think the EU pharmacovigilance legislation will also apply here. However we are in the grey area as there is no longer a marketing authorisation.

Appreciate any feedback people may have from experience.