Abstract

Transforming a scientific concept into a viable pharmaceutical product is a prolonged and highly complex endeavour. The target product profile (TPP) and product profile characteristics (PPC) are key strategic tools that bridge development gaps by providing structured guidance for clinical planning and manufacturing. In the context of product labelling, the TPP and PPC ensure alignment with regulatory requirements, market expectations and patient needs. Together, they promote transparent, indication-based labelling and consistent communication of essential product information, leveraging expertise from cross-functional stakeholders.

The developer’s global regulatory team assumes full ownership and accountability for initiating and maintaining the TPP and PPC. These updates are guided by patient safety priorities and ensuring alignment with the approval process. Global regulators such as the US Food and Drug Administration (FDA) and other bodies such as the World Health Organization (WHO) have initiated databases capturing TPP elements, including labelling attributes, to enhance alignment across stakeholders and support rapid responses during health crises. 

This article explores the evolving role of the TPP and PPC in labelling development, global harmonisation efforts, and their many benefits. This article also provides an in-depth explanation of TPP and PPC concepts and uses relevant case studies to facilitate effective management of regulatory approvals across internal and external stakeholders.