The label of a pharmaceutical product is of great importance and allows for its safe and effective use. Speaking of CCDS, it is a master labeling document. This is also used as a reference document for the national label. CCDS is a document that plays an important role in representing the pharmaceutical company’s position on the product. Read and get to know more about CCDS here, with Artixio.
What Is Company Core Data Sheet (CCDS)?
The medical term ‘’CCDS’’ expands as Company Core Data Sheet. It is a document that is created by the marketing authorization holder (MAH) and contains, in addition to all the relevant safety information, material relating to indications, dosing, pharmacology and areas that are non-safety related. The CCDS is maintained at a central level by the MAH to represent the company’s position on the product, and from which local/national labels will be prepared.
What Are The CCDS Requirements?
To draft and prepare the CCDS, it requires relevant safety, efficacy and other information as well which is discussed in the following content.
Structure Of CCDS
The structure of CCDS is an internal company decision, but it can be based on a local format like:
SPC (Summary of Product Characteristics) Format
USPI (United States Prescribing Information) Format - Old
USPI Format (PLR - Patient Labelling Rule) - New
Components Of CCDS
The following are the mandatory and the optional contents to be included in CCDS.
Therapeutic class
Indications
Dosage and Administration
Contraindications
Warnings/Precautions
Drug Interactions
Pregnancy/Nursing
Special Populations
Adverse Reactions/Side Effects
Overdosage
Chemistry (optional)
Structure (optional)
Mechanism of Action (optional)
Clinical Pharmacology (optional)
Clinical Studies (optional)
Animal Toxicity (optional)
Why Is CCDS Important?
The Company Core Data Sheet of a product is important because it offers countless benefits. The CCDS will act as a master labelling document which is maintained by the marketing authorization holder at a central level so as to represent the company's position on a product. This is used as a reference for national labels. We all know that once a drug has entered the market it undergoes changes from time to time. When the drugs are exposed to a larger population than the one with which the trials are conducted, there is always a chance to receive new information about the drug or the product. This information will be updated in the CCDS, which in turn is crucial for product labelling.
As it contains safety information, warning and precautions, the healthcare providers can refer to this and avoid unnecessary outcomes and improve patient healthcare. Moreover, it ensures regulatory compliance and also serves as scientific evidence indicating the safety and efficacy of the drug in the market. The chance for drug abuse is also very less as it clearly states the information on dosage, administration and overdosage.
CCDS helps companies track their product performance and take necessary steps to improve product development. In addition to this it acts as a reference point in pharmacovigilance sector to evaluate the significance of the reported adverse effects.
Things To Keep In Mind While Updating CCDS :
There are certain elements that are related to the Chemistry, Manufacturing and Controls (CMC) or product quality sections which are entirely optional in CCDS. Not all companies incorporate these elements in their CCDS, but the companies that include these should allow the CMC teams to update these elements in the CCDS as and when necessary. Since the CMC teams tend to make any changes or updates at the same time as the safety team, it is important that both teams coordinate. Regulatory information updates that affect the product, new product information and updates are the main things to consider while updating CCDS.
Why Pharma Companies Outsource CCDS Support?
Since CCDS serves as a foundation for regulatory documents, expertise is required for its proper development. Outsourcing it to the service providers can help to prepare a well-developed document. It is also time saving and cost effective than hiring and training an internal team. In addition to this, outsourcing helps the company to focus on their core strength.
Artixio Consulting provides global labeling services like Core Data Sheet, Core Safety Information, etc., and we can help you by giving you all the support that you need. Discover more about our regulatory services by contacting us through info@artixio.com
FAQs About CCDS
How is CCDS different from a national label?
Content from national labels may differ from the CCDS for different reasons. Information specific to the region, ethnic and patient variability, differences in medical practices, etc. are some of the reasons.
What are the common challenges in managing CCDS?
Some common challenges are identifying the originator label, keeping up with regulatory updates, lack of harmonized label structure, differences in procedures, conversion of information between different formats, compliance with product update etc.
How often should CCDS be reviewed or updated?
CCDS should be reviewed or updated regularly whenever a new safety information or health authority recommendation is available. Some other reasons can be any changes to the product or to the originator label etc.
Who is responsible for maintaining CCDS in a pharmaceutical company?
The MAH, Marketing Authorization Holder is responsible for maintaining the CCDS based on relevant national authority requirements and health authority recommendations in the regulatory market.
What are the consequences of non-compliance with CCDS standards?
Regulatory penalties, recalling of the product are the most common consequences occurring with CCDS standards non-compliance.
When Is CCDS Needed?
CCDS is needed during the process of drug development, specifically at the time of clinical development process, regulatory approval stages and to support regulatory submissions for marketing authorization.
Comments