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Labeling Digitization: Manage Data, Not Documents

By Author: DDiSmart
Total Articles: 1

A prescription drug product label is a compilation of information about the safe and effective use of the product prepared by the manufacturer or marketing authorizing holder (MAH) and approved by the health authorities in the respective marketed zones. Drug labeling is becoming more prominent that involves dealing with multiple functional dynamics with required specialized attention, stakeholders (supply chains), and constantly evolving regulatory environment across the globe. Marketing authorization holder is responsible to maintain the valid and updated information in their approved or marketed product labels throughout of its lifecycle globally where the products are being marketed.

Creation and maintenance of labels or label documents is a continual process to any MAH since they have to collect and implement all the necessary changes in the label documents for regulatory approvals and compliance. Health authorities also communicate to the MAHs on updating information via notifications/amendment notification letters. In this regard, MAHs are responsible to collect product specific updated information from various sources and update core label information for each product on a time basis.

Core Data Sheet (CCDS/CDS) Importance

Core information or core label data (Core Data Sheet or CDS) is an internal regulatory document which serves as the company's global reference document for a product. It is used to communicate the company's position to appropriate stakeholders worldwide for the inclusion of safety and efficacy information on country-specific labels. The core safety information includes mainly therapeutic class, indications, dosage and administration, contraindications, drug interactions, pregnancy/lactation, special populations, adverse drug reactions, warnings/precautions, and over dosage.

HQ Role

Global labeling management or headquarters team is responsible to prepare and maintenance of CCDS for each marketed product of the company. Once the CCDS is prepared and approved it should be distributed to all the local country affiliates where the product is being marketed. However, CCDS maintenance is a widen challenge to the MAHs that requires timely receive, review, validate and update the information pertaining to safety & efficacy changes to the marketed products. There are several ways to obtaining safety updates such as periodic safety reports, PMS, health authority notifications, and regulatory platform information (FDA, PRAC recommendations, etc). The headquarter team is responsible to get all the above information to meet regulatory compliance in the existing documents. Once the CCDS is updated and approved the same document will be distributed to all the country affiliates to implement the necessary changes in the local labels as applicable. In case of any difference in the label content from core information to local labels, headquarter team will provide the response for each difference in local labels after evaluating and concerning the country or region-specific requirements. Thus headquarter team will provide continuous support to all the local affiliates on labeling information. Read more…

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