EMA Endorses EU IT Roadmap

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-11-2015 14:03


The European Medicines Agency (EMA) Management Board has endorsed the European Union (EU) Telematics Strategy and Implementation Roadmap 2015-2017, which had already been adopted by the Heads of Medicines Agencies in July 2015. The roadmap provides a concrete outline of the EU Telematics strategy and its implementation from 2015 to 2017 describing how specific projects will address the information-technology (IT) needs arising from European pharmaceutical policy and legislation. The roadmap builds on the EU Telematics Strategy 2014-2016, which was endorsed in 2014.

The work of the EU medicines regulatory system in promoting and protecting public health is underpinned by common IT services, which are put in place and maintained by EU Telematics. EU Telematics facilitate efficient and effective coordination and exchange of information on medicines between the EMA, the European Commission, and the national competent authorities for medicines regulation in the EU.

Projects included in the roadmap cover areas such as governance structure implementation, clinical trials regulation, management and processing of electronic submissions for marketing-authorization applications and safety information on human and veterinary medicinal products, data integration, and pharmacovigilance.

The overall implementation framework is expected to benefit by maximising the efficiency of IT communication across the EU regulatory network and will be regularly updated as the programs evolve.

Source: European Medicines Agency 

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