Labeling

Biosimilars and interchangeability with biologics has been a topic of discussion for regulatory authorities worldwide, including their definitions and varying requirements per regions. However, a key requirement or standard for interchangeability requires applicants to provide sufficient information to demonstrate bio similarity. This reflects in the biosimilars labelling requirements where prescription drug and biological product labels […]

Biopharmaceutical product labelling is a multifaceted undertaking that spans various products and markets, encompassing diverse formulations and dosages.  The challenge lies in consistently upholding pharmaceutical labelling compliance throughout this intricate process. Ensuring pharmaceutical labelling compliance involves following regulatory requirements and guidelines when developing and updating product labels, such as Summary of Product Characteristics (SPC), Patient

Structured Product Labeling (SPL) was first introduced in 2006 by the US Food and Drug Administration (FDA) with the aim to enhance the communication of product, quality, and facility information to label submissions. The move to the electronic Extensible Markup Language (XML) format, compared to the PDF format, has further streamlined drug label review processes,