Can more than one drug name appear in a CCDS? Who is the proper party to approve CCDS updates and revisions?This articles offers a framework and helps in understanding the role of the cross-functional teams and their undertakings that are involved in creation of a CCDS.
The Company Core Data Sheet (CCDS) or Core Data Sheet (CDS) is an internal company document that is owned by the marketing authorization holder (MAH)/ pharmaceutical company which presents its position on the safety profile of any drug. The CCDS serves as the basis for prescribing a medication and for global advertising and promotional activities. The purpose of having a CCDS firstly is to align the labeling of any said drug product across the globe and to have the “Reference Safety Information” for the assessment of the aggregate reports for the product.
Depending on the policy and structure in the company, the CCDS is owned by regulatory or safety line functions; but in the true sense CCDS is a cross functional document, that is updated/created with inputs from various functional groups in a pharmaceutical company.
Cross-Functional Team Liaises to Perfect Company Core Data Sheets
The CCDS cross-functional team would comprise of experts from Global Labeling, Chemistry, Manufacturing and Controls (CMC), Clinical/Medical Affairs, Pharmacovigilance/Drug Safety, Pharmacokinetics and Pharmacodynamics (PKPD) functions and also legal and marketing in special cases. In a cross functional labeling team, the regulatory or the global labeling group plays the role of the leader to drive the process by ensuring the other teams provide input on time and bringing consensus on the new content. Members of the cross functional teams are responsible for finalizing the content of sections pertaining to their area of expertise.
A Guide for Understanding CCDS Classification: Given below are the classification of the CCDS sections based on the responsible function:
Chemistry, Manufacturing, and Controls (CMC): “Name Of The Medicinal Product”, “Qualitative and Quantitative Composition”, “Pharmaceutical Form”;
Clinical/Medical Affairs: “Therapeutic Indications”, “Posology and Method of Administration”,
Pharmacovigilance/Drug Safety: “Contraindications”, “Special warnings and precautions for use”, “Drug Interaction”, “Fertility, Pregnancy and Lactation”, “Effects on Ability to Drive or Use Machines”, “Undesirable Effects”, “Overdose”;
Pharmacokinetics and Pharmacodynamics (PKPD): Pharmacodynamic properties, Pharmacokinetic Properties;
Toxicology (Animal studies): Pre-clinical Safety Data (Acute and chronic toxicity, carcinogenicity, teratogenecity, fertility).
Multiple Stakeholder Expertise Helps in Collaborative Process
Various functional groups perform indepth data research and evaluation to provide textual input for sections they are responsible for in the CCDS. Sections in the CCDS require input from multiple line functions as the information in these sections may impact other sections; information may have a cross-reference to other sections in the CCDS as applicable.For example, “Posology and method of administration” would have information pertaining to the normal adult population as well as the special population like pediatrics, geriatrics, patients with renal impairment and patients with hepatic impairment, as applicable.Information on these special populations would depend on the PK/PD parameters of the drug. The details of PKPD data would be discussed in the pharmacokinetics and pharmacodynamics section of the CCDS. The effect on dosing would be calculated by the clinical expert, based on the data and would be mentioned in the section “Posology and Method of Administration”. If the safety expert on analysis of PKPD data finds any activity which can cause adverse event in any of the special populations, then a caution statement must be added in “Warnings and Precautions” section of the CCDS.
Understanding Diverse Viewpoints & Impacts
As the same information would impact three sections of the CCDS which are owned by Clinical (Posology and Method of Administration), Safety (Warnings and Precautions) and PKPD (Pharmacokinetics and Pharmacodynamics section) experts, the final text in these sections should be discussed and agreed-upon by these experts. Hence it is important that all the concerned functions agree on the content in the overlapping sections. This process will also aid in constant review of the document.
Moreover, working with cross-functional teams allows diverse perspective on any topic and helps in having in-depth discussions. It also provides an opportunity to look in to the overall risk-benefit ratio of the product instead of looking into risk and benefit in isolation, as both Clinical and Safety functions work in cohesion in the cross functional team. In conclusion, the cross functional team provides diversity of knowledge, thinking perspectives, additional review of the content from other functions and in depth data analysis while ensuring consistency of information in the CCDS.