Regional Labeling Services

Freyr's Regional Labeling Services are designed to serve multiple functions across several regions and countries. As part of our regional labeling expertise, we develop strategy and support for local and regional labeling compliance, ensuring all regulatory standards are met in each market.

A label communicates information to Healthcare Professionals (HCP), patients, and consumers about the benefits and risks of the product. It also offers advice on the effective and safe use of the same product. As the landscape shifts, Regulatory labeling requirements demand global and local harmonization, with label content directly affecting product approval and post-market safety.

Safety labeling changes are a critical element in the labeling lifecycle, often triggered by updated clinical data, adverse event reporting, or new health authority guidance. Biopharmaceutical companies rely on 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 the product labeling is negotiated between biopharmaceutical companies and Regulatory authorities. Safety labeling changes must align with the most current reference labels, supporting pharmacovigilance and compliance.

 Achieving core-to-local label harmonization saves time and resources. Regional regulatory labeling must frequently accommodate local labelling standards, particularly in markets with unique structures, like the Canada Product Monograph, which requires additional scientific detail beyond standard patient or HP leaflets.

While many countries offer a two-tiered system, Canada Product Monograph follows a three-tiered system, further emphasizing the complexity of regional labeling compliance. Companies must monitor safety labeling changes and adhere to frequent HA updates using automated tools and expert oversight.