Optimizing Regulatory information management (RIM) is something every pharmaceutical company must plan for. Defining RIM can be a challenge, however, since there’s no ICH standard for what should be done. But right now your organization is dealing with the reality of managing several drug submissions weekly for multiple medicinal products. That includes keeping track of the regulatory activities associated with these submissions, attempting to manage agency commitments, and organizing and sharing the daily updates of agency correspondence. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of missed deadlines, delayed market approval, and non-compliance.
The FDA requirement to submit in eCTD format as of May 5, 2017 does not apply to Ad Promo submissions. As of today, the timeline for requirement of these submissions in eCTD is to be determined. Similar to the majority of regulatory requirement updates at FDA, the date effective clock doesn’t start counting down until guidance is finalized. The key indicator for Ad Promo eCTD submissions is the document titled – Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs. If FDA follows precedent, Ad Promo submissions will be required in eCTD format 2 years after the final guidance is published.
Many international regulatory affairs professionals have come to dread the phrase “Module 1 Change” in the past decade. What looks like a simple reshuffling of leaf titles or the addition of a few new submission types grows into a much more complex problem to solve. Those of you in regulatory operations see on thing in large red letters – VALIDATION. The European Union is taking its turn in 2016. The EU M1 v3.0 final specification was published in October 2015 and is set to take effect July 1, 2016. The specifications become mandatory on October 1, 2016.
What has changed is the FDA’s methodology for collecting and organizing metadata associated with each application. The old M1 specifications arranged information in a flat structure, i.e., amendments could be related to other amendments. In the new M1 specifications, metadata is arranged in a hierarchy.
When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.