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Sweetening the bitter pill: Turning medicinal product regulation into business value

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April 06 2016

Have you ever run out of a prescription medicine while traveling and tried to present your home prescription to a pharmacy in another country? The ambiguity at an international level of how medicines are packaged, marketed, sold, consumed and dosed can sometimes hinder better healthcare. Indeed, consider a medicine that might be recorded as having an adverse effect in one country and needs to be uniquely identified in other countries for the management of its recall.

MDM provides a platform for the successful management of regulations in the pharmaceutical industry

The Identification of Medicinal Products (IDMP) is a regulatory framework designed at an international standard level to provide unique identifiers for medicines. IDMP standards, coming into force in July 20161, will be used to exchange medicinal product information between regulators, pharmaceutical companies, clinical trials sponsors and other worldwide data sources. Although a European initiative, the FDA in the USA and other countries such as Japan have also started alignment and adoption schemes.

The medicinal product identification mechanisms are defined by the International Organisation for Standardisation (ISO) who already manage regulatory, pharmaceutical and healthcare standards2. IDMP set standards for product names, active and inactive ingredients, packaging, manufacturers, authorisations, units of measure, dosage forms, etc. However, the potential representation of this information is more complex as products are organised and reconstituted according to the needs of the business.

Get the most out of the regulations with MDM
Despite the regulatory nature and the complexity of the new requirements, companies should take advantage of its implementation to see how the standards can help add value to existing processes. Indeed, the solutions to manage medicinal product information, such as Master Data Management (MDM) platforms, might also be used to support other business critical information that also needs to be shared and governed at an enterprise level. For example, clinical trials information, financial reference data, customer data and employee data are often common to many business processes.

IDMP is part of a wider regulatory framework for clinical trials (EU Clinical Trial Directive, 2001/20/EC) that was adopted in 2004. The directive aimed to protect the rights and safety of clinical trial participants, as well as simplifying and harmonising procedures in clinical trial implementations across Europe. Despite its application, reductions in the number of clinical trials conducted across Europe (number of applications recorded at 25% decrease in 2011 from 20073) and increased costs in administrative, insurance and staff requirements, have led the EU to revise the directive.

This year (2016) sees the arrival of new regulations that were adopted in 2012 and based on amendments to the original directive. The amendments seek to make the processes of submission and assessment quicker, more cost effective and more transparent. IDMP forms an important part of the directive whose success is ultimately measured by performance in patient healthcare, wherever it is provided.

An important MDM implementation benefit that should be considered is the ability to collect existing information from existing systems and render it usable across the enterprise by applying data quality, information organisation and distribution controls. For example, IDMP might be best supported from existing data sources rather than building new ones. The solution could also be used to stretch far back across the supply chain to collect as much information as possible to provide an end-to-end product lifecycle view that could enhance traceability and recall mechanisms.

MDM provides a platform for the successful management of such regulatory requirements, helps to integrate future requirements more easily, and provides additional value in the management of key business information that can be shared with confidence, across the enterprise.

MDM for pharmaceutical

 [1] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp&mid=WC0b01ac058078fbe2
[2] https://www.iso.org/obp/ui/#iso:std:iso:11615:ed-1:v1:en 
[3] http://ec.europa.eu/health/files/clinicaltrials/2012_07/impact_assessment_part1_en.pdf  


Darren has spent much of his career in software sales consulting, working in a variety of industries. During the last 15 years, he has specialised in information management, advising global, blue chip companies on their data governance strategies. Today, Darren provides leadership in helping Stibo Systems grow its business by demonstrating how our unique technology can help accelerate our customers’ digital transformation journeys.
Darren Cooper hat einen Großteil seiner beruflichen Laufbahn in der Software-Vertriebsberatung verbracht und dabei verschiedene Branchen kennengelernt. Über die letzten 15 Jahre hat er sich auf das Thema Datenverwaltung spezialisiert und in dem Zusammenhang namhaften globalen Unternehmen bei der Entwicklung ihrer Data Governance-Strategien geholfen. Heute unterstützt Cooper das Wachstum von Stibo Systems, indem er verdeutlicht, wie sich mithilfe unserer einzigartigen Technologie die digitale Transformation unserer Kunden beschleunigen lässt.



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