News -
Following the implementation of XEVMPD, new legislation, based on five new ISO IDMP
standards, is due to come into force in 2016. In an article in Clinical Trials Insights Rune Ringsholm Bergendorff, advanced business consultant at NNIT, explains how pharmaceutical companies will need to adapt business processes across the whole organisation.
Right now, Danish and European pharmaceutical companies are gearing up to comply with the ISO standards – designated IDMP – that come into force in the EU on 1 July 2016. The ISO IDMP standards require information from many areas of the pharmaceutical business, including regulatory affairs, research and development, manufacturing and distribution.
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. ISO IDMP will transform your regulatory IT strategy.
Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.
Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).