Let's face it, for those of us in the life sciences companies, the phrase "product registration" often conjures images of endless paperwork, labyrinthine regulations, and a process that feels more like navigating a maze than a streamlined pathway to market. We meticulously compile dossiers, track countless data points, and brace ourselves for the inevitable back-and-forth with regulatory bodies.
In an era where regulatory requirements are becoming more complex and globalized, Regulatory Information Management Systems (RIMS) are no longer optional—they are essential. The life sciences industry is experiencing a digital revolution, and RIMS software stands at the forefront of this transformation, enabling organizations to manage regulatory submissions, compliance, and data efficiently.
In today's rapidly evolving business landscape, organizations across life science industries face stringent Regulatory requirements. Compliance with these regulations is not only crucial for legal and ethical reasons but transforming end-to-end operations with a unified RIMS suite. With Regulatory Information Management System (RIMS), businesses now have a powerful tool to ensure compliance and streamline their Regulatory processes. In this blog, we will delve deeper into the role of Regulatory Information Management in unlocking the Regulatory landscape for compliance.
On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.
The new version enables web-based forms to replace the existing electronic application forms (eAF), making them more efficient. The web-based forms project is called DADI (Digital Application Dataset Integration), and its implementation is planned to start in October 2022 with an initial web form for variation procedures only.
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.