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What Sponsors Need to Know: eCTDs & New Regulatory Standards for Pharmaceutical Advertising & Promotional Materials

What Sponsors Need to Know: eCTDs & New Regulatory Standards for Pharmaceutical Advertising & Promotional Materials
05 April 2017

Our very own Senior Regulatory Affairs Manager at Synteract, Thomas Christensen, RAC, recently spoke about “Lessons Learned for First Time OPDP Submissions, Promotional Material, and Labeling” at the DIA Regulatory Submissions, Information, and Document Management Forum in Bethesda, MD. His article on the topic was also published in Pharmaceutical Executive on March 14th.

Electronic common technical documents (eCTDs) are already the preferred format to submit regulatory information in many countries, and in May 2017, they will become the required standard for submitting New Drug Applications, Biologic License Applications, Abbreviated New Drug Applications and Drug Master Files to the FDA. Submissions not complying with the requirements stated in the eCTD Guidance will receive a technical rejection and not be filed.

As a result, the FDA has updated its eCTD structure to include promotional labeling, and while the guidance to submit promotional material in eCTD format is not yet final, the change is coming. Whether currently submitting via paper or a hybrid electronic format, this requirement will add complexity and room for error, making it all the more important to prepare.

Regulatory managers and other submitters, and their organization, need to make time to understand important updates, allow for set up and anticipate complexity of file and submission formats. And planning earlier, rather than later, can help to build and maintain a knowledge base and ensure a smoother processes for initial submissions.  Read Thomas’ full article for details.

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