Abstract

A VISION TO DIGITALIZE THE EUROPEAN REGULATORY FRAMEWORK

Ishita Kathuria* and Minakshi Garg

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Abstract

In an attempt to make the application submission process easier and faster, the European Medicines Agency in the year 2003 initiated the concept of eSubmissions to get rid of the physical paper copies. This resulted in the re-use of master data, quick navigation with the help of XML backbone, efficient review system, transparent and secure exchange of data. The hassle-free submissions are now made through various online portals. Also, a common point of contact was developed through repositories and collective databases from where data can be easily accessed. Along the way, the Agency has taken multiple steps to ensure digitalization at every step with the introduction of eSignatures, electronic Product Information, IRIS and SPOR portals. Here, we have tried to consolidate various initiatives for the human medicinal products submissions taken by the European Medicines Agency and their timelines leading to the digitalization of the regulatory framework in the European Union.

Keywords: eSubmissions, Digitalization, European Medicines Agency, Regulatory framework.