News

November 2022
Real Regulatory Tips and Insights

published 12 Dec 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 November 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Clinical study reports and the ICH template

When preparing a clinical study report, it’s always worth remembering that the ICH E3 structure and content guideline is guidance and not a template, as noted in Q1 of the E3 question and answer document (available at https://database.ich.org/sites/default/files/E3_Q%26As_R1_Q%26As.pdf). ICH E3 is not an absolute set of requirements and flexibility may be needed depending on the nature of each particular study.

EMA guidance on CSR signatures and appendices

Two useful guidance documents for CSRs are available on the EMA website, which cover inclusion of appendices to CSRs in MAAs (https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-appendices-clinical-study-reports-marketing-authorisation-applications_en.pdf), and designating the coordinating investigator signature of CSRs (https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-coordinating-investigator-signature-clinical-study-reports_en.pdf).

Clinical Trial Comparators

Do you have comparator drugs in your EU clinical trial? Keep section D of your initial Clinical Trial Application form as open as possible. If your protocol allows, it is possible to identify comparators via active substance or INN, and not specify the manufacturer or marketing authorization holder on the form. Maintaining this flexibility may allow you to change supply during the trial, without needing to submit an amendment to authorities.

Clinical Trials: Planning for EU sites

If you are planning to run a clinical trial in the EU, check the Clinical Trials Facilitation Group website (https://www.hma.eu/ctfg.html) "key documents list" for the latest guidance. The CTFG guidance is not included in EudraLex Volume 10, but does include important EU guidance on, eg, clinical trials safety, contraception recommendations, and trial management during the COVID-19 pandemic, amongst others.

 

 

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