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European Biopharmaceutical Review

Organisation Optimisation

Mature products are often still sold in substantial numbers with a widespread global footprint, despite being long past their marketing exclusivity. They are critical to an organisationís growth and revenue, alongside the development of new ones. Since they have been on the market for a while, they open up the possibility for marketing authorisation holders (MAHs) to manage processes in a more efficient and cost-effective manner Ė allowing them to consider an integrated safety, regulatory and benefit-risk model.

Their Importance


While at the end of their lifecycle, mature products are still likely to be sold well into the future and have a crucial role in the healthcare industry across different markets. Their proven effectiveness and safety profiles make them particularly significant in emerging markets where they can be introduced, manufactured and distributed more quickly. Since the cost of maintenance is substantially lower than that of a new product, pharmaceutical companies can focus on tailoring them to individual market needs, which is usually done through formula innovation, changing the dosage form or altering the packaging.

A blockbuster drug passing its patent exclusivity has a significant financial impact for the manufacturer. As generics enter the market, most firms have to re-evaluate the cost spent on product maintenance and minimise expenditure in order to sustain their profitability. As the industry has matured, the requirement for adequate documentation to maintain compliance with local regulations across many of the emerging markets has grown. Maintaining regulatory dossiers and managing labels is necessary to uphold licenses, along with pharmacovigilance (PV) activities. Noncompliance with any stipulations can result in serious penalties, often with significant financial implications.

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David Balderson is Global Vice President Safety Operations at Sciformix Coporation and has over 18 years of experience in safety and regulatory operations. Throughout his career, he has been a key driver of process improvement initiatives, from the development of processes to support the EU Clinical Trial Directive through to the development of an electronic interface between the study and safety databases. David holds a BSc in physiology and pharmacology as well as a PhD in neuroscience, both from the University of Manchester, UK.
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