In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form called the Digital Application Dataset Integration (DADI). The European Medicines Agency (EMA) designed DADI as a long-term replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.
While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging. Therefore, it is crucial to have a dedicated platform to handle the lifecycle changes of product labeling.
As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
The eCTD publishing and submission is a cumbersome process that requires the cooperation of multiple individuals from various departments within the organization. Also, it is paramount that Standard Operating Procedures (SOPs) and clear expectations are established to streamline the process, which requires ample time and proper planning.