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Volume: 4 Issue: 6
(June 2017)

em announces launch updated eudravigilance system releases sme action plan european medicines agency (‘em announced 22 may 2017 improved


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EMA announces launch of updated EudraVigilance system and releases SME Action Plan

The European Medicines Agency (‘EMA’) announced on 22 May 2017 that an improved EudraVigilance database system for the collection and monitoring of suspected adverse reactions will launch on 22 November 2017, with the EMA Management Board having signalled that the new system has reached full functionality. The updated system, which reports on medicines either authorised or being studied in the EEA, aims, inter alia, to simplify the reporting of individual case safety reports, to offer enhanced search and data analysis capabilities and to support larger volumes of use via increased system capacity and performance.

“In a nutshell, the new system will streamline the current procedures and make the system easier, more efficient and more transparent,” said Prof Vincenzo Salvatore, Of Counsel at BonelliErede. “It will also further improve and facilitate cooperation and the sharing of information between concerned regulatory authorities and the international organisations and bodies responsible for public health.”

Users of the new system - national competent authorities, marketing authorisation holders and sponsors of clinical trials - will now need to prepare for the system’s launch. To help facilitate this, the EMA is to run training webinars and in-person training, and the new EudraVigilance system will be available in a test environment from 26 June 2017. “In preparation for the official launch of the system, users of the system have to adapt their processes and local IT infrastructures in order to ensure they are compatible with the new system,” notes Elinor Pecsteen, Associate at Jones Day.  

Additionally the EMA has released a number of documents that will be of interest for the digital health sector. On 30 May 2017 it released its ‘action plan for small and medium-sized enterprises (SMEs)’ (‘Action Plan’), part of the EMA’s work to support innovation in the pharmaceutical sector. The EMA has identified as an objective of this Action Plan to ‘Encourage the registration of stakeholders in the medtech and digital health sectors with the EMA through targeted communications.’ “The Action Plan seeks to support such companies through all stages of drug development and to further engage with sectors adjacent to pharmaceuticals, for example companion diagnostic technologies, medical technologies industries and digital health, in light of Europe’s new medical device legislation, advances in pharmacogenomics and advanced therapies,” explains Dr Lincoln Tsang, Partner at Arnold & Porter Kaye Scholer LLP. Companies designated as SMEs by the EMA enjoy certain financial and other benefits; however at present designation is limited only to manufacturers involved in the research and development of medicines. “The proposal as suggested by the EMA seemingly seeks to extend the scope of the SME designation scheme to companies working in sectors which support the research and development of medicines,” continues Dr Tsang. “The initiative recognises the potential for personalised medicines to transform clinical practice through use of companion diagnostics; and in fact payers are increasingly mandating diagnostics to be applied to ensure proper use of new therapeutics. The increasingly informed and active consumer and the advances in digital and information technology will spur the growth of personalised in selection and optimisation of new treatments.”

Lastly, the EMA began on 23 May 2017 the public consultation on its draft ‘Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol’ (‘Draft Guideline’), which contains information on who should report a ‘serious breach,’ what such a breach can consist of, and how it should be reported. A notable takeaway from the Draft Guideline is that in the EMA’s view ‘Loss of data due for example to servers’ breakdown’ constitutes a ‘serious breach.’ “In order to mitigate the potential breaches related to possible loss of data, sponsors and vendors are expected to have appropriate IT measures in place - such as back-up or recovery sites - and must ensure that they have taken all the necessary measures to be in the position to retrieve relevant information in case the system breaks down,” said Prof Salvatore.

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