EMA Endorses Roadmap for Regulatory Reforms

The European Medicines Agency is planning to develop an EU portal and database as a single entry point for clinical trial data submissions by May 2016.

By July 2016, the EMA plans to finalize a guideline supporting the adoption of ISO standards for identification of medicinal products.

Other projects included in a three-year EMA roadmap include upgrading the Eudravigilance clinical trial module to provide electronic reporting of annual safety reports and suspected unexpected serious adverse reactions. The module will address postmarket safety through simplified and centralized reporting, better quality data and improved analysis and tracking of labeling changes.

Looking to 2018, drugmakers will be able to submit applications electronically via a single submission portal.

The EMA’s management board endorsed the EU Telematics Strategy and Implementation Roadmap 2015-2017 in early August.

View it at www.fdanews.com/8-15-EMA-IT.pdf. — Jonathon Shacat


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