CCDS Pharma refers to the application of the Company Core Data Sheet (CCDS) within the pharmaceutical industry. The CCDS is a critical document that summarizes essential safety information about a drug product.
In more detail:
The Company Core Data Sheet (CCDS) is the central document that the Marketing Authorization Holder (MAH), or the pharmaceutical company, prepares. This document contains crucial safety information regarding a particular drug, including but not limited to:
- Indications: What the drug is approved to treat.
- Dosage: How much of the drug should be administered.
- Pharmacology: How the drug works within the body.
- Safety Information: Including contraindications, warnings, and precautions.
The CCDS serves as the foundation for product labeling and risk management activities worldwide. It aims to harmonize safety information across different regions while accommodating local regulatory requirements. This harmonization leads to more consistent and accurate communication about drug safety.
Therefore, "CCDS Pharma" is essentially using the CCDS as a standard operating procedure within a pharmaceutical company to ensure product safety and consistency of drug information globally.
