Impending IDMP deadline means it is time to act

Published: 3-Nov-2015

Data interoperability is key to improving the efficiency of drug development and authorisation. Katrin Spaepen, Director of Strategy, Vault Submissions, Veeva Systems, looks at impending requirements of the Identification of Medicinal Products standards

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The European Medicines Agency (EMA) has instituted regulatory requirements for Identification of Medicinal Products (IDMP), a set of standards defined by the International Organisation for Standardisation (ISO). Despite broad expectations that the deadline is to be extended, compliance is currently required by 1 July, 2016. IDMP requires life sciences companies selling products in Europe to assemble data sourced from multiple systems and produce a single output file for submission.

This standard will ultimately benefit life sciences companies by compelling them to align business processes and their supporting systems in ways that lead to dramatic efficiency improvements

The emergence of IDMP and other cross-disciplinary standards is driving interoperability, while encouraging life sciences companies to find ways to co-ordinate across various systems, departments and companies – including external service providers.

The initiative has enjoyed cross-border support, with Europe officially adopting the standard, the US and Canada voicing support, and other regions expected to follow suit. This standard, like many others, will ultimately benefit life sciences companies by compelling them to align business processes and their supporting systems in ways that lead to dramatic efficiency improvements. Historically, efficiency improvements were not enough to drive widespread change, but with new regulations, there’s no more waiting it out.

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