News

September 2022
Real Regulatory Tips and Insights

published 17 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 September 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

New Role in IRIS

New role in IRIS: The EMA is developing a new role within IRIS for orphan drug designations, called IRIS Industry Global Coordinator. Anyone assigned this role will be able to create, view, edit, submit and withdraw ANY application associated with their Organisation, whether or not they have been added explicitly to the submission. The EMA anticipates that the new role will go live in Q1 2022.

eAF for Variations and the Classification Guidelines

QPPV Details Update for UK National Licences

For UK national licences, if there have been no changes to the identity, location and contact details of the responsible QPPV from those entered in XEVMPD at the end of 13 December 2020, and you do not anticipate any changes, these details still need to be notified to the MHRA by 30 June 2022. Full details are available at: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf#notification-of-qppv-and-psmf-details-to-the-mhra-by-existing-holders-of-uk-marketing-authorisations.

MHRA to retire eSUSAR Website

The MHRA is retiring the eSUSAR website used for the submission of suspected unexpected serious adverse reaction (SUSAR) reports from Clinical Trials of Investigational Medicinal Products (CTIMP). The website will be decommissioned at the end of September 2022, and only SUSARS submitted via the ICSR Submissions portal will be accepted from 01 October 2022. Further details are available on the MHRA Inspectorate blog: https://mhrainspectorate.blog.gov.uk/2022/08/03/decommission-of-esusar/

EU CTIS – Part II Doc Required for Part I Only Submission

f you are preparing a clinical trial authorisation application in the EU Clinical Trials Information System (CTIS) portal, where the dossier is limited to Part I of the assessment report, please be aware that, at present, you need to include the Part II document confirming that the sponsor will collect and process data in compliance with Union Law on Data Protection (item R in Annex I to Regulation (EU) No 536/2014); otherwise it’s not possible to submit the application in CTIS

 

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