This article talks about the overview on Quality Review of Document (QRD) of medicines in Europe
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 Holderâ€™s (MAHâ€™s) perusal.
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This article talks about the FDA guidance on regulatory submission of Real World Data(RWD) and Real World Evidence(RWE) for the evaluation of a drug product safety and efficacy.