Addressing eCTDs And New Regulatory Standards For Pharmaceutical Advertising And Promotional Materials

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

Therefore, the FDA has updated its eCTD structure to include promotional labeling. Though the guidance to submit promotional material in eCTD format is not yet final, the change is coming.  This requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.