• ePI Labeling – An Overview

    In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.

    We have come a long way in the journey of Product Information (PI) and Quality Review Documents (QRD) since then.

  • Quality Review of Document (QRD) - An Overview

    To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages. A dedicated Working Party (WP) is assigned by the European Medicines Agency (EMA) for Quality Review of Documents (QRD). The WP develops, reviews, and updates templates as per the authority requirements for Marketing Authorization Holder’s (MAH’s) perusal.