EMA issues IT improvement plan

The European Medicines Agency (EMA) has released a three-year action plan to improve its use of information technology and boost the regulation of medicines within the European Union (EU).

The EU Telematics Strategy and Implementation Roadmap 2015–2017 covers IT improvements in governance structure implementation; clinical trials regulation; management and processing of electronic submissions for marketing-authorisation applications; safety information on medicinal products; data integration and pharmacovigilance. A detailed note on the plan said these changes would 'improve efficiency in all regulatory procedures by making best use of IT'. It would also reduce duplication and the cost of developing and maintaining local IT systems; optimise the value of existing IT systems by improving interoperability; provide an integrated and cost-effective way for the pharma industry to interact with EU regulators in the EU; help the sharing of high quality data; and hasten compliance with regulations.

For instance, the plan involves the development of a single submission portal, to integrate electronic application forms, with links to master-data and datasets. This would reduce 'the need for industry to resubmit information already held by the regulators', it said in the plan.

Meanwhile, an EU medicines web portal would be developed as a 'free, unbiased, scientifically-valid source of medicinal product information on the Internet'. It will replace the EudraPharm human database, and provide an EU-wide view of a medicine’s lifecycle. This would take in EU and nationally-authorised product information, EU-level adverse drug reaction (ADR) data, searchable EU dictionaries of substances and products, and clinical trial summaries.