Introduction 

For pharmaceutical companies operating globally, maintaining consistent and compliant product information is one of the most complex aspects of lifecycle management. The Company Core Data Sheet (CCDS) serves as the company’s global reference document, defining the core safety, efficacy, and prescribing information that should be reflected across worldwide product labels. However, one common misconception is that the CCDS can simply be copied into regional product information documents such as the European Union’s Summary of Product Characteristics (SmPC). 

The SmPC is a legally binding regulatory document that must comply with European legislation, European Medicines Agency (EMA) guidance, national competent authority requirements, and product-specific scientific assessments. While the CCDS provides the foundation, the SmPC must be carefully adapted rather than replicated. 

This article explores the relationship between the CCDS and the SmPC, explains why direct copying is neither appropriate nor compliant, and highlights the roles, responsibilities, and regulatory processes involved in maintaining aligned yet region-specific product information. 

1. Understanding the CCDS and the SmPC

Although both documents communicate essential product information, they serve different purposes and are governed by different requirements. 

What is the Company Core Data Sheet (CCDS)? 

The CCDS is an internal global company document that contains the sponsor’s agreed core information on: 

• Therapeutic indications 

• Dosage and administration 

• Contraindications 

• Warnings and precautions 

• Drug interactions 

• Use in special populations 

• Undesirable effects 

• Overdose information 

• Clinical pharmacology 

The CCDS represents the company’s global scientific position and acts as the reference for preparing country-specific product labels. 

What is the Summary of Product Characteristics (SmPC)? 

The SmPC is an officially approved regulatory document within the European Union that provides healthcare professionals with comprehensive prescribing information. 

Unlike the CCDS, the SmPC: 

• Is approved by European regulatory authorities. 

• Has legal status. 

• Follows a mandatory format defined by EU legislation. 

• Reflects the benefit-risk assessment accepted for the EU market. 

Roles and Responsibilities 

Global Safety Team 

• Maintains and updates the CCDS based on emerging safety data. 

Global Labelling Team 

• Coordinates global labelling strategy and CCDS revisions. 

Regional Regulatory Affairs 

• Translates CCDS updates into region-specific submissions. 

• Ensures compliance with EU regulatory requirements. 

Medical Writing 

• Prepares high-quality SmPC variations while maintaining scientific accuracy. 

2. Why the CCDS Cannot Simply Be Copied into the SmPC

Although the CCDS serves as the starting point, several factors prevent direct transfer into the SmPC. 

Different Regulatory Objectives 

The CCDS reflects the company’s global scientific perspective. 

The SmPC reflects the conclusions accepted by European regulators after reviewing available evidence. 

Consequently, some information may: 

• Be accepted globally but not approved in the EU. 

• Require different wording. 

• Require additional supporting evidence. 

• Be omitted until regulatory approval is granted. 

Different Legal Status 

The CCDS is an internal company-controlled document. 

The SmPC is a legally binding regulatory document approved by competent authorities. 

Every statement included in the SmPC must be scientifically justified and accepted during regulatory assessment. 

Different Formatting Requirements 

The SmPC follows the standardized QRD (Quality Review of Documents) template issued by the European Medicines Agency. 

This template specifies: 

• Mandatory section numbering 

• Required headings 

• Standard terminology 

• Consistent wording 

• Defined presentation of safety information 

Simply copying CCDS text would often fail to comply with these formatting requirements. 

3. Scientific and Regulatory Differences That Require Adaptation

Several scientific and regulatory considerations require careful evaluation before updating the SmPC. 

Benefit-Risk Assessment 

Different regulatory authorities may interpret emerging safety data differently. 

Examples include: 

• Different frequency categorization for adverse reactions 

• Different contraindications 

• Different monitoring recommendations 

• Additional warnings applicable only within certain regions 

Approved Indications 

The approved therapeutic indications in Europe may differ from those approved elsewhere. 

As a result: 

• Certain efficacy data may not apply. 

• Safety statements linked to non-approved indications cannot be included. 

• Dosing recommendations may differ. 

Population Differences 

Regional considerations may influence product information, including: 

• Local prescribing practices 

• Standard of care 

• Epidemiological differences 

• Availability of alternative treatments 

Therefore, safety communication must remain relevant to European clinical practice. 

Roles and Responsibilities 

Medical Safety Physicians 

• Evaluate emerging evidence. 

Benefit-Risk Teams 

• Assess global safety impact. 

Regional Experts 

• Evaluate applicability within EU legislation. 

Regulatory Affairs 

• Ensure scientific conclusions are appropriately reflected in submissions. 

4. Regulatory Procedures for Updating the SmPC

Updating the SmPC involves a structured regulatory process rather than simple document editing. 

Step 1: Signal Detection and Safety Evaluation 

New information may arise from: 

• Individual Case Safety Reports (ICSRs) 

• Signal detection activities 

• Clinical trials 

• Scientific literature 

• Post-Authorization Safety Studies (PASS) 

• Regulatory authority recommendations 

Step 2: CCDS Revision 

The Global Safety and Global Labelling teams determine whether the new information warrants an update to the CCDS. 

Scientific justification is documented and reviewed internally. 

Step 3: Regional Gap Assessment 

Regulatory Affairs compares: 

• Existing SmPC 

• Updated CCDS 

• Current EU regulatory requirements 

• Product-specific approvals 

Any differences are carefully assessed before submission. 

Step 4: Variation Submission 

If changes are required, a variation application is prepared in accordance with applicable EU variation procedures. 

Supporting documentation may include: 

• Updated SmPC 

• Revised Package Leaflet (PL) 

• Updated labelling 

• Clinical and safety justifications 

• Benefit-risk assessment 

Step 5: Regulatory Review and Approval 

The competent authority evaluates the proposed changes before approving updated product information. 

Only after approval can the revised SmPC become effective. 

5. Challenges in Global Labelling Alignment

Maintaining consistency across global labelling while ensuring regional compliance presents several challenges. 

Common Challenges 

• Divergent regulatory decisions 

• Different implementation timelines 

• Country-specific labelling requirements 

• Multiple language translations 

• Frequent safety updates 

• Simultaneous lifecycle activities 

Poor coordination may result in inconsistencies that increase compliance risks during inspections. 

Best Practices 

Organizations can improve labelling consistency by: 

• Establishing a global labelling governance process. 

• Maintaining version-controlled CCDS documentation. 

• Conducting structured gap analyses before regional updates. 

• Promoting collaboration between Pharmacovigilance, Regulatory Affairs, Medical Writing, and Medical Affairs. 

• Implementing regular labelling review meetings. 

• Maintaining comprehensive change documentation. 

6. The Importance of Cross-Functional Collaboration

Successful labelling management requires collaboration across multiple departments. 

Pharmacovigilance 

• Detects and evaluates new safety information. 

• Initiates safety-driven labelling changes. 

Regulatory Affairs 

• Determines submission strategy. 

• Manages regulatory interactions. 

• Coordinates variation approvals. 

Medical Writing 

• Drafts high-quality SmPC updates. 

• Ensures consistency with QRD templates and regulatory expectations. 

Quality Assurance 

• Verifies document control. 

• Ensures compliance with internal procedures. 

Global Labelling Teams 

• Maintain the CCDS. 

• Coordinate implementation across regions. 

Strong communication between these functions helps ensure that product information remains scientifically accurate, regionally appropriate, and inspection ready. 

7. Building a Robust Global Labelling Strategy

An effective global labelling strategy goes beyond maintaining consistency—it ensures that healthcare professionals and patients receive accurate, evidence-based information that reflects local regulatory expectations. 

Organizations should establish processes that: 

• Monitor emerging safety information continuously. 

• Evaluate global and regional benefit-risk profiles. 

• Maintain alignment between the CCDS and regional labels. 

• Document scientific rationale for labelling decisions. 

• Ensure timely implementation following regulatory approval. 

By recognizing that the CCDS is the global foundation—not the final regulatory document—companies can achieve both global consistency and regional compliance. 

Transforming global safety information into compliant regional product information requires careful scientific and regulatory review. Baupharma supports pharmaceutical companies through its Pharmacovigilance, Regulatory Affairs, and Medical Writing services, helping organizations maintain alignment between CCDSs and regional labeling, prepare high-quality regulatory documents, and meet evolving regulatory requirements across global markets. 

Key Takeaways 

• The CCDS is a global company reference document, while the SmPC is a legally binding EU regulatory document. 

• Information contained in the CCDS cannot be copied directly into the SmPC without scientific and regulatory assessment. 

• Differences in approved indications, benefit-risk evaluations, regional requirements, and formatting necessitate careful adaptation. 

• Updating the SmPC requires structured regulatory procedures, including safety evaluation, gap assessment, variation submissions, and regulatory approval. 

• Cross-functional collaboration between Pharmacovigilance, Global Labelling, Regulatory Affairs, Medical Writing, and Quality Assurance is essential for compliant product information management. 

• A well-governed global labelling strategy ensures consistency across markets while meeting region-specific regulatory expectations and protecting patient safety.