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Achieving consistency in pharmaceutical labeling across countries is crucial for ensuring regulatory compliance and maintaining a unified brand message. To effectively manage label harmonization, companies must focus on three key pillars:
A clear organizational structure
Defined roles and responsibilities in label governance
A robust technology strategy
Regulatory requirements vary significantly between regions, which can lead to discrepancies across labels if a solid governance process is not in place.
Labeling leaders have the responsibility from the point of the product labeling strategy through to the roll out into local markets ensuring that all teams—global and local—are working towards the same goals. This involves managing the impact of label content across regions and ensuring that the justification for label positioning is consistent, from global labeling teams to local market references.
What Makes Label Harmonization So Challenging?
One of the main challenges in product label harmonization is that country requirements differ. As a result, the information provided may be unique to each country or in some way more detailed as compared to other countries. Recently, the use of technologies to track label change requirements, manage work allocation, plan submissions, handle and review documents, and integrate information systems-along with enterprise resource planning systems-has made it essential to adopt a digital strategy for pharma labeling. This strategy ensures continuity of data and content throughout the labeling process and helps labeling leaders ensure compliance and expedited delivery throughout the label lifecycle.
Discover how effective label lifecycle management can ensure patients receive the right information at the right time
Understanding Similarities & Differences in Product Labels across Markets
By examining the distinct format and structures of product labels from different countries like the US, EU, Japan, and Canada, we can understand the similarities and differences in label content and the benefits of having a harmonized label.
Here’s an example of how to map related sections across the four mentioned markets. “” indicates the section is included, while “” indicates the section is not applicable.
| Sections of Pharmaceutical Label | USPI | EU SmPC | Japan Label | Canada Label |
|---|---|---|---|---|
| Highlights of Prescribing Information | ||||
| Indications and Usage | Clinical Particulars | |||
| Dosage and Administration | Posology and method of administration | |||
| Dosage Forms and Strengths | Pharmaceutical Form | |||
| Contraindications | ||||
| Warnings and Precautions | Precaution concerning indications, Important Precautions, Important General Precautions | Serious Warnings and Precautions box | ||
| Adverse Reactions | Undesirable Effects | |||
| Drug Interactions | ||||
| Use in Specific Population | Fertility, Pregnancy and Lactation | Precaution concerning patients with specific backgrounds | ||
| Drug Abuse and Dependence | ||||
| Overdosage | Precaution concerning Dosage and Administration | |||
| Description | Qualitative and Quantitative Composition | Composition and Product Information | ||
| Clinical Pharmacology | Pharmacological properties | |||
| Non-clinical Toxicology | Pre-clinical safety data | |||
| Clinical Studies | ||||
| How Supplied/Storage and Handling | Special precaution for Storage; Special precaution for disposal and handling | Packaging | ||
| Patient Counselling Information/Medication Information | ||||
| Effects on ability to drive and use machines | ||||
| Pharmaceutical particulars | Partial | Partial | Partial |
This comparative analysis highlights the role of tools like QRD templates and standardized product templates in ensuring consistent regulatory compliance across global markets.
Label Content Trends: Uniformity, Variability, and Regional Nuances
The Real Impact of Varying Label Details
Frequent Updates: Sections that require more detail, such as Warnings and Precautions and Adverse Reactions, are likely to be updated more frequently. This is because new safety data and adverse event reports necessitate regular revisions to ensure up-to-date information.
Harmonization Challenges: Harmonizing pharmaceutical labels across regions can be challenging due to these differences. For example, the US might need to add more detailed Drug Abuse and Dependence information to align with its standards, while the EU might need to include more comprehensive Pharmaceutical Form details.
For instance, consider the Adverse Reactions section. If a new adverse reaction is identified, the US label might need to be updated with detailed clinical data, including the nature and mechanism of the reaction. In contrast, the EU label might focus on the frequency and severity of the reaction, requiring updates that emphasize statistical data and risk assessment. Another example is the Warnings and Precautions section. If new safety data emerges indicating a potential risk, the US label would update this section with relevant information on the risk and recommended safety measures. In Japan, however, the label would need to update multiple sub-sections such as Precaution Concerning Indications, Important Precautions, and Important General Precautions to provide a thorough explanation of the new risk, including specific precautions and recommendations for healthcare providers. These examples illustrate the complexities involved in ensuring that labels are both compliant with regional regulations and effectively communicate critical safety information to healthcare providers and patients.
Why Do Product Labels Differ Across Markets?
There are four reasons why labeling is different across markets including regulatory requirements, healthcare practices, cultural, and legal considerations.
1. Regulatory Frameworks
2. Healthcare Practices
3. Cultural and Language Differences
4. Legal and Liability Considerations
The Toolkit for Managing Product Label Content Harmonization
Explore this case study on how an American multinational used NLP to automate pharmaceutical labeling operations, ensuring compliance with US Prescribing Information (US PI) and EU regulatory requirements..
Strategies for Achieving Harmonized Labels
For a deeper dive into digital labeling, read the blog: Step-by-Step Guide: Achieving Desired Outcomes through Digital Labeling, and explore best practices for building a future-ready labeling operation.
Conclusion
The analysis of pharmaceutical labels from various countries reveals distinct approaches to meet specific regulatory compliance and informational needs. The US product label stands out as a patient-centric approach, ensuring clear communication of critical information through detailed subsections for specific populations and clinical trial experiences. The Canadian product label is notable for its segmented approach, dividing information into three main parts for healthcare professionals, scientific data, and consumers. This detailed segmentation enhances clarity and usability, ensuring that each audience receives relevant and comprehensive information. Japan’s product label is distinguished by its detailed precautions and safety information, with multiple subheadings under “Precautions”. This thorough structure ensures that all potential risks and safety measures are clearly communicated, providing a comprehensive overview that other countries’ labels may not match in detail. Similarly, EU SmPC is unique in data presentation including regulatory details, detailed sub-headings on “Pre-clinical Safety Data” and “Effects on ability to Drive and Use Machines”. Each health authority has focused on areas they believe are important, which has implications that require both diligence in understanding these requirements and assurance of consistency across markets to maintain a harmonized product label throughout the product's lifecycle in each market.
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