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Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and
Marion Mueller1, David J Lewis2,3, V Kishore K Darisi4
1Manager Safety Risk Management, Global Drug Development, Novartis Pharma GmbH, Holzkirchen, Germany. Marion.mueller@novartis.com.
Pharmaceutical Medicine
|December 8, 2020
Summary
Creating and maintaining Company Core Data Sheets (CCDS) for generic products presents challenges. Harmonizing pharmaceutical labeling, particularly safety information, is crucial for end-user safety and risk communication.
Area of Science:
- Pharmaceutical sciences
- Regulatory affairs
- Drug safety
Background:
- Pharmaceutical product labeling is essential for safe and effective medication use.
- Company Core Data Sheets (CCDS) are central to national labeling and represent a company's product stance.
- National labels may diverge from CCDS due to regulatory requirements and local market data.
Purpose of the Study:
- To discuss the process, challenges, and concepts in creating and maintaining CCDS for generic products.
- To identify areas for process improvement in generic product CCDS updates.
- To advocate for labeling harmonization, especially for safety information, to enhance end-user safety.
Main Methods:
- Discussion of the creation and maintenance processes for CCDS in generic pharmaceuticals.
- Analysis of key parameters for CCDS update improvements.
- Argument for labeling harmonization and its benefits for risk communication.
Main Results:
- Identified challenges and key concepts in CCDS management for generics.
- Highlighted parameters for optimizing CCDS update processes.
- Emphasized the importance of labeling harmonization for safety.
Conclusions:
- CCDS creation and maintenance for generic products require careful consideration of processes and challenges.
- Labeling harmonization, particularly for safety information, is vital for patient safety and effective risk communication.
- The topic warrants consideration by the International Council for Harmonisation (ICH) for standardization.
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