The regulatory landscape is continuously evolving towards automation and harmonisation in terms of data and standards. The International Organization for Standardization (ISO) sets standards for the identification of medicinal products (IDMP), which is one of the hot topics for discussion among regulatory agencies and the pharmaceutical industry. Various regulatory bodies are working towards the implementation of IDMP, with the European Medicines Agency (EMA) being a prominent force. While full IDMP implementation will be achieved phase-by-phase, the EMA has adopted several initiatives towards the implementation of ISO IDMP. The digital application dataset integration (DADI) project is the first step in this direction, with an intent to implement web-based application forms that would support efficiency and better interoperability. It will eventually replace the current interactive portable document format (PDF)-based electronic application forms (eAFs) with new web-based application forms hosted on a dedicated portal.

This article explains various aspects of European Union (EU) DADI such as scope, implementation timeframe, pre-requisites from industry, procedural aspects, user experience with centrally authorised products (CAPs), and the benefits and challenges of using a web-based form as compared with the current eAF. This article also serves as a roadmap for sponsors to prepare for the upcoming implementation of DADI.