News

February 2023
Real Regulatory Tips and Insights

published 6 Mar 2023

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 February 2023 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

 

Digital Application Dataset Integration (DADI) project – web-based variation form for human medicinal products launching in October 2022

The European Medicines Agency will launch the electronic application form (eAF) variations web form in October 2022 – this will be the first release of a web-based variation form for human medicinal products, and will be limited to centrally authorised products at go-live. A subsequent release of the form in March 2023 will cover all types of European variations procedures. Further details are available on the eSubmissions website: https://esubmission.ema.europa.eu/cessp/cessp.htm

 

eTMF Quality Control and Audit Preparation Advice

Don’t wait for notification of Health Authority Audit to begin considering Sponsor Functional QC (SFQC) Checks on your eTMF! Real Regulatory specialises in performing SFQC checks on eTMF. Inadequate or incomplete filing of eTMF documentation can be a cause of major findings in an audit but is easily allayed by consistent and pre-emptive SFQCs.

 

Industry Single Point of Contact (i-SPOC) Registration Required

MAHs should register their Industry Single Point of Contact (i-SPOC) on the EMA IRIS platform by 2 September 2022. The i-SPOC will inform and facilitate rapid communication with EMA about the supply and availability of critical medicines identified in the context of ‘public health emergency’ or a ‘major event’. Registration in IRIS is a two-step process and MAHs should allow 5-10 working days for the process to be completed. EMA has updated the IRIS user guide and published a video demo to support companies with registration. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/availability-medicines#industry-contact-points-for-supply-and-availability-of-critical-medicines-(new)-section https://www.ema.europa.eu/documents/other/iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf

 

 

 

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