Regulatory News - January 2019

Journal Publication of Interest

Boehringer Ingelheim (BI) and the University of Basel describe An Industry Experience with Data Sharing, with BI - as a member sponsor - in listing studies on ClinicalStudyDataRequest.com (CSDR) for data sharing.

EMA Temporarily Suspends Clinical Data Publication, and updates Policy 0070 Implementation Guidance.

Will EMA Retrospectively Publish Clinical Data When the Suspension is Lifted?

Question from Sam Hamilton to EMA (29 Nov 18): “As of 01 Aug 2018, EMA has suspended all new activities related to the publication of clinical data. Can EMA confirm if submissions made between 02 Aug 2018 and the (future) date of the lifting of the suspension - will or will not be subject to retrospective publication?”

Response from EMA (10 Dec 18): “…EMA is ONLY processing applications adopted by CHMP up to the first quarter of 2017 and which were submitted to the Agency by 31 July 2018 (upon receipt of an Invitation letter).

We cannot currently comment on how the process will be resumed and whether clinical data will be published retrospectively. EMA will contact concerned applicants/MAHs before the restart of clinical data publication, once its relocation to Amsterdam is completed.

We appreciate any preparatory work done by companies regarding their upcoming CDP package submissions, however, and EMA is asking companies simply to pause any ongoing work until further notice.”

Resources
1. EMA published a meeting report titled "Data anonymisation - a key enabler for clinical data sharing" on their 30 Nov to 01 Dec 18 joint workshop with the US-based Multi-Regional Clinical Trials (MRCT) Centre.
2. TransCelerate Biopharma has released a clinical study report template.