Why a Company Core Data Sheet (CCDS) is required and what is its significance for the marketing authorization holders (MAH).

Creation, maintenance and updating the CCDS costs money to the MAH and requires lot of time and effort. Keeping the CCDS up to date is a continuous process, and as soon as significant new information is noted it should be reviewed for updating the CCDS.

MARKETING AUTHORIZATION HOLDERS: APPROVALS

The MAH has to submit the labels to the local competent authority and get it approved in the countries where they want to do business. After approval, this will become the official label for that country. The CCDS as per the ICH E2C (R1) is defined as “It is a common practice for MAHs to prepare their own “Company Core Data Sheet” (CCDS) which covers material relating to safety, indications, dosing, pharmacology, and other information concerning the product.

A practical option for the purpose of periodic reporting is for each MAH to use, as a reference, the safety information contained within its central document (CCDS), which will be referred to as “Company Core Safety Information” (CCSI).” The local label (SmPC or USPI) is the official label for a product in that country and is approved by its local health authority.

This local label can be a prescriber’s information, patient information or the label on the carton. Local health authority reviews and approves the label in accordance with its rules, regulations and guidelines. Hence, the final local label might have difference with the proposed label submitted by the MAH. Hence, the local label might deviate from the company position on a product.

HEALTH AUTHORITIES: LABELING TEMPLATE

Health authorities have their own template for the labels, which is different from others. For example, European Union Summary of Product Characteristics (EU SmPC) template has a section on “driving and using machines” and even if there is no relevant information available for this section the local label should contain this section explaining the same.

However, in the USPI or various other country labels this section is not a part of the template and the information related to driving and using machines would only be included in local label if there is enough evidence to support any impact (actual or potential) on the ability to do work which require alertness like driving and using machines, in that case this information can be added to the appropriate section e.g. the warnings or precautions section.

Hence, it is important for the MAH, especially when doing business in different countries, to have the labeling document which can be used as a reference document globally. This leads to a question that what should be the template of the CCDS, should it follow any local template e.g. EU SmPC or the USPI or should it use a hybrid template which can cover minimum safety information and leave anything specific to local templates.

GLOBAL HARMONIZED LABELING

It is more important for the companies doing business in multiple countries and regions as inclination to a local label template for the CCDS will pose challenges in having the harmonized labeling globally. The hybrid template can be a better option to cater the needs of all the countries globally.

It should be kept in mind while developing the hybrid template that it should contain all those sections which are related to safe use of the product and allows inclusion of the minimum safety information in the CCDS. However, the local label can still have any country specific information and any information mandated by the local HA.

CCDS: AN IMPORTANT GUIDE FOR THE PRODUCT PROMOTIONAL CONTENT

CCDS is not only used to create the harmonized labeling or for pharmacovigilance but it is also important guide for the product promotional content. It can act as a tool to control the promotional content centrally.

To serve all the purposes discussed above the CCDS for any product need to be updated on the regular basis, and as soon as any new safety information comes to knowledge. The new information should be added to the CCDS only if it has enough scientific evidences to support the inclusion and should not be driven or influenced by any business interest of the company.

This should be discussed in details in the rationale for the CCDS update and should be authored by the well qualified experts. MAH should also ensure that their promotional material is in line with the labeling.

CCDS also plays an important role in the process of pharmacovigilance, the assessment of expectedness of the spontaneous ADRs in ICSRs for reporting to the HA, is done by using the local label. While, for the assessment of the aggregate reporting (e.g. PSURs) RSI/CCDS is required.