Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenan
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CURRENT OPINION
Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance Marion Mueller1 · David J. Lewis2,3 · V. Kishore K. Darisi4 · Sebastian Horn5 Accepted: 24 October 2020 / Published online: 8 December 2020 © The Author(s) 2020
Abstract Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company’s position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products’ CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.
Key Points The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company’s position on a generic medicinal product. Some challenges in the generic labelling processes are highlighted, including common procedures and opinions. * Marion Mueller [email protected] 1
Opportunities for improvement are discussed, including labelling harmonisation and IT solutions.
Manager Safety Risk Management, Global Drug Development, Novartis Pharma GmbH, Holzkirchen, Germany
2
Chief Medical Office and Patient Safety, Global Drug Development, Novartis Pharma GmbH, Wehr, Germany
1 Background
3
Department of Pharmacy, Pharmacology and Postgraduate Medicine, University of Hertfordshire, Hatfield AL10 9AB, Hertfordshire, UK
4
Safety Labeling Manager CDS&SD, Global Drug Development, Novartis Healthcare, Hyderabad, India
5
Global Drug Development, Head Patient Safety Generics, Novartis Pharma GmbH, Holzkirchen, Germany
Labelling of a pharmaceutical product plays a vital role in the safe and effective use of that product. Such information must be provided to end-users, including consumers and prescribers, for decision making on the usage of the pharmaceutical product, and must be available in multiple form
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