August 2022
Real Regulatory Tips and Insights

published 12 Oct 2022

Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in August 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

EMA eSubmission Gateway Web Client-Upgraded Syncplicity Portal

The EMA eSubmission Web Client portal has been upgraded to the Axway Syncplicity portal. Applicants will need to access the new portal to send submissions to the EMA; previously registered users should have received a password reset link from Axway Syncplicity by e-mail. Guidance on using the Syncplicity portal is available on the eSubmission website:

Clinical Studies & Sponsor Responsibilities

For a sponsor of a clinical study, it must be remembered that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, even if some or all of the tasks associated with conducting the study are outsourced to third parties. Sponsor oversight of a study is a key element of the sponsor’s responsibilities under ICH E6(R2)

Mandatory Use of OMS in eAF for all EMA Submissions

From the end of September 2021, new sites and organisations to be registered for a medicinal product as part of any procedure submitted to the EMA (e.g. initial application, line extension, variation, renewal), must be registered beforehand in the Organisation Management Service (OMS) for use in the electronic application form (eAF) (for further details please see Applicants will be requested to register missing sites during validation, which could then delay the start of the procedure.


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