MANUFACTURING
FINDING A PATH TO GLOBAL END-TO-END LABELLING
As health authorities’ local requirements evolve and their quality expectations increase, many companies are often faced with difficult choices when it comes to developing a multilingual regulatory labeling infrastructure that is scalable, cost efficient and future-proof. This article will discuss the various methodologies, strategies, and resources that can be implemented to enable effective end-to-end labeling. Christophe Djaouani, EVP Regulated Industries, SDL
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perating in one of the most demanding and highly regulated environments, pharmaceutical companies face the constant challenge of managing medicinal product information for regulatory labelling submissions that comply with regional and national agency requirements. High standards demanded by regulatory agencies during the submissions process – which varies by country – puts enormous pressure on firms to ensure that the filings are effectively coordinated between the central team and local affiliates and that every element of their application is flawless.
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P H A RM A F O C U S A S I A
ISSUE 39 - 2020
The approval process is a long and arduous journey and keeping product information up-to-date in multiple languages requires mobilising many resources centrally and locally. Local regulatory affairs stakeholders may outsource or be directly involved in the translation, review and formatting process. This constant handling of the documentation can cause inconsistencies and quality issues and, most importantly, limit the time to be allocated to main regulatory activities. As regional and national authorities' requirements evolve and their quality expectations increase, many companies
are faced with difficult choices when it comes to developing a multilingual regulatory labelling infrastructure that is scalable, cost efficient and future-proof. To maximise global reach and reduce time to market, pharmaceutical companies should consider employing new technologies to enhance compliance of their product information with regional and national regulatory filing requirements in multiple languages and geographies. Label management is complex, spanning the entire lifecycle of a medicinal product, and has global and regional implications. Those involved in label
