Regional Labeling Services : Overview

Product labeling is designed to serve multiple functions across several regions and countries through regional labeling services. On a basic level, national and regional Health Professionals (HP), patient, and consumer labeling communicate information about the benefits and risks of the product. It also offers advice on the effective and safe use of the same product.

Biopharmaceutical companies take advantage of the national/regional HP labeling to determine whether they could expect a suspected adverse drug reaction for expedited reporting to the local Regulatory authorities. The exact labeling content of national and regional product labeling is generally negotiated between biopharmaceutical companies and Regulatory authorities. At the same time, it would benefit organizations to achieve core-to-local label harmonization, saving time while aligning with region-specific labeling requirements. Label safety alignment must also be ensured with the reference label.

While a lot of countries and regions offer a two (02)-tiered labeling system with patient and consumer information as well as HP labeling, Canada offers a three (03)-tiered system with some detailed scientific information beyond what is included in the “regular” HP labeling.