Global Labeling: Streamline with Tech and Outsourcing

Global Labeling: Streamline with Tech and Outsourcing


Product labels are an essential part of the marketed product as they provide comprehensive information about product safety and usage of drugs or devices. In recent days, labeling process has become increasingly rigorous in health care domain. Health authorities such as US FDA, EMA, Health Canada, and PMDA have their own standards for labeling to commercialize products in their region. Product labels must also comply country-specific regulations (local requirements) to commercialize in any particular country or region. Product label includes leaflets, package inserts, package leaflets, prescribing information, packaging and artwork IFU (Instructions For Use), patient brochures. Healthcare authorities made mandate that each drug or device should maintain a clean and proper label for its marketing position. In case of misbranded if its labeling proves false or misleading in the information results issuing the warring letters, product recalls, withdrawals or any other serious jurisdictions by the healthcare authorities.

Global Labeling and Challenges:

Global labeling is a complex process and there are often functional dependencies between the different departments. Most of labeling challenges are arising from company acquisitions, mergers, multiple products approved in multiple countries and local label changes. The following are extreme challenges during company mergers and acquisitions which include inadequate transition process, lack of tracking system, poor communication between head quarter to local affiliates. While companies marketing multiple products across the region are complex and cost exponential criteria and may led to regulatory compliance. The label content in different jurisdictions continues to “drift” away from the content presented in CCDS, disintegrating the intention of a “core” as the misalignment and continues to expand. In addition, frequent changes in emerging market regulations contribute update the label information periodically. This causes additional burden to global manufacturers that they need maintain the track record for label changes by coordination between headquarters and local affiliates.

Prospects in Global Labeling Process Streamline with Tech and Outsourcing:

Pharmaceutical companies are currently looking at some or more of the labeling processes at outsourcing. Technology vendors have processes to address the labeling challenges to safety, content, post marketing changes as per regulations. The labeling tools are providing an automated text comparison, content management, language support and customized workflow management. It accompanies the automation of labeling processes to reduce cost, resources and ensure greater stability of content in a wide range of products in the pharmaceutical industry that addresses the challenge of different labeling operations, translations in emerging markets as per regulatory requirements.

Regulations Pertaining to Medical Device Labeling

In US region labeling requirements are contained in 21 CFR 801 and specify the minimum requirements to commercialize all devices. The directive's EU MDR (European Medical Device Regulation) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. As per section 13 of Annex I, all medical devices must bear a label identifying the name and address of the manufacturer. GHTF (Global Harmonization Task Force, GHTF) main was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems with main objective is to harmonize national provisions regarding the safety, health protection, and performance characteristics of medical devices, including the relevant certification and inspection procedures. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

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