A Company Core Data Sheet (CCDS) is a central reference document used by pharmaceutical companies for product information and labeling. It contains important information about a medicine, including indications, dosage, pharmacology and safety information.
The CCDS is prepared and maintained by the marketing authorization holder and can serve as a reference when local or national product labels are developed or updated. It also has an important role in pharmacovigilance because the Company Core Safety Information (CCSI) is contained within the CCDS.
What Is a CCDS in Pharmaceuticals?
CCDS stands for Company Core Data Sheet. It contains the company’s core information about a pharmaceutical product, including safety information as well as details on indications, dosing, pharmacology and other relevant product information.
The CCDS is maintained as the company’s core product-information document. Local or national labeling may then be developed or updated with reference to this document, subject to the requirements of the relevant regulatory authority.
Structure of a Company Core Data Sheet
A CCDS generally follows a structured format, but there is no single universal template used by every pharmaceutical company. It brings together core product information such as indications, dosage and administration, pharmacology, safety information and other relevant product information.
Depending on the company’s global labeling framework, it may include information such as:
- product identification and composition
- therapeutic indications
- dosage and administration
- contraindications
- warnings and precautions
- drug interactions
- pregnancy and lactation information
- use in special populations
- adverse reactions
- overdose
- pharmacology and mechanism of action
- other relevant clinical or product information
Some CCDSs may also contain additional information such as clinical pharmacology, clinical studies or non-clinical information, depending on the product and the company’s format.
The exact headings and order can therefore differ between companies.
The safety information contained in the CCDS forms the Company Core Safety Information (CCSI). CCSI is used as reference information for determining whether adverse reactions are listed or unlisted for periodic safety reporting.
CCDS in Pharmacovigilance
A CCDS plays an important role in pharmacovigilance because it contains the Company Core Safety Information (CCSI), which serves as reference safety information for the product.
In periodic safety reporting, the CCSI is used to determine whether an adverse reaction is listed or unlisted against the company’s core safety information. Changes to the CCDS or CCSI may also need to be considered during periodic safety evaluation and when local product information is reviewed. This listed/unlisted assessment for periodic reporting should not be confused with expected/unexpected assessment used in expedited safety reporting.
CCDS Updates and Lifecycle Management
A CCDS is not a static document. It may need to be updated when new information changes the company’s core product or safety information.
Updates may involve changes to:
- contraindications
- warnings and precautions
- adverse reactions
- drug interactions
- indications
- dosage and administration
- other relevant product information
For periodic safety reporting, the reference product information should be dated and version controlled. Significant changes to the CCDS or CCSI during the reporting period should also be described in the relevant safety report and considered during ongoing safety evaluation.
CCDS and Local Product Labeling
A CCDS serves as the company’s core reference document, but it does not replace the approved product information used in individual countries.
Local product information can differ from the CCDS because local regulatory authorities may require different wording or modifications. The CCSI definition itself recognizes this, stating that the core safety information is intended to be listed in countries where the product is marketed except where a local authority specifically requires a modification.
When the CCDS is updated, companies may need to assess whether related changes are required in local product information and follow the applicable regulatory process in each market. EMA pharmacovigilance guidance also shows that differences between the CCDS and local or national product information need to be considered in periodic safety reporting.
CCDS vs CCSI: What Is the Difference?
The CCDS and CCSI are closely related, but they are not the same document or concept.
The Company Core Data Sheet (CCDS) contains the company’s broader core product information, including safety information as well as information on indications, dosing, pharmacology and other aspects of the product.
The Company Core Safety Information (CCSI) is the safety information contained within the CCDS. It is used as reference information for determining whether adverse reactions are listed or unlisted for periodic safety reporting.
In simple terms:
- CCDS = the broader core product-information document
- CCSI = the safety information contained within the CCDS
Things to Keep in Mind While Updating a CCDS
CCDS updates should be based on new information that can affect the company’s core product or safety information. The reason for an update should be documented, and the revised content should be reviewed through the company’s established labeling and pharmacovigilance processes.
When updating a CCDS, companies should consider:
- new safety findings
- changes to contraindications, warnings or precautions
- newly identified adverse reactions or interactions
- changes to indications, dosage or administration
- relevant regulatory decisions or new scientific information
- whether related local product information also needs to be reviewed
If the Company Core Safety Information (CCSI) changes, the revised version should be used in subsequent periodic safety reporting as appropriate.
Why Pharma Companies Outsource CCDS Support
Managing a CCDS usually involves teams such as global labeling, pharmacovigilance and regulatory affairs. Some companies also use external support for CCDS work when they need extra expertise, help across several products or markets, or support with regular updates.
External support can be used for activities such as:
- CCDS drafting and development
- CCDS updates and lifecycle maintenance
- CCSI review and maintenance
- comparison of CCDS content with local product information
- tracking and assessing labeling changes
- preparation of supporting documentation for global labeling activities
Outsourcing does not transfer the marketing authorization holder’s regulatory responsibilities. The MAH remains responsible for the product information and for meeting applicable regulatory requirements.
Conclusion
A Company Core Data Sheet (CCDS) keeps the main product information in one place for use across different markets. It covers details such as indications, dosing, pharmacology and safety, and is also used in labeling and pharmacovigilance work.
Because product information can change over time, the CCDS should be reviewed and updated when new information affects the company’s core product or safety position. The CCSI contained within the CCDS is particularly important for periodic safety reporting and ongoing safety evaluation.
For companies managing products across multiple markets, a well-maintained CCDS can support more consistent labeling decisions and make it easier to assess when local product information may need to be updated.
Artixio supports pharmaceutical companies with CCDS development, review, updates and global labeling activities. Learn more about our regulatory artwork and labeling services.
FAQs
Why is a Company Core Data Sheet important?
A CCDS gives the marketing authorization holder a central reference for core product information across markets. It supports consistent global labeling, ongoing safety evaluation, and review of local product information when changes occur.
How is a CCDS different from a national label?
A CCDS is the company’s core global reference document for product information. A national or local label is the product information approved or required by the regulatory authority in a particular market.
The local label may differ from the CCDS because of country-specific regulatory requirements, approved wording, indications, warnings, or other local considerations.
What are the common challenges in managing a CCDS?
Common challenges can include keeping the CCDS aligned with new safety information, tracking regulatory changes, assessing differences between the CCDS and local labels, and coordinating updates across multiple markets.
Differences in local labeling formats and regulatory procedures can also make global harmonization more difficult.
How often should a CCDS be reviewed or updated?
There is no single universal update frequency for every CCDS. A CCDS should be reviewed when new information may affect the company’s core product or safety information. This can include new safety findings, changes to indications or dosing, regulatory decisions, or other significant product information.
Who is responsible for maintaining the CCDS?
The Marketing Authorization Holder (MAH) is responsible for preparing and maintaining the CCDS as the company’s core product-information document.
The actual review and update process may involve functions such as pharmacovigilance, global labeling, regulatory affairs and medical teams, depending on the company’s internal processes.
What is the difference between CCDS and CCSI?
The CCDS contains the company’s broader core product information.
The Company Core Safety Information (CCSI) is the safety information contained within the CCDS. It can be used as reference safety information for determining whether adverse reactions are listed or unlisted in periodic safety reporting.
