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European Medicines Agency - Draft Proposal on Transparency Addendum

In a recent public consultation, the European Medicines Agency (EMA) solicited stakeholders’ views about its draft proposal for a transparency addendum pertaining to the content of the EU portal and database that will be set up for the implementation of the Clinical Trial Regulation No 536/2014. The express aim of the latter is to provide more information on clinical trials and their result in Europe. The consultation on the ’Draft proposal for an addendum, on transparency, to (...)

Medicines shortages in Europe: A disconcerting operational and communication challenge

The issue of medicine supply shortages has been highlighted by EPHA and its members throughout 2013, and it once again took centre stage at a recent workshop organised by the European Association of Hospital Pharmacists (EAHP). Already in winter, a common position on the issue has been drafted by members of the European Medicine Agency’s Patients’ and Consumers’ / Healthcare Professionals Working Party. 2014 EAHP Congress, Barcelona The 19th annual EAHP (...)

The European Medicines Agency (EMA) publishes list of drugs under additional monitoring

As one of the deliverables of the pharmacovigilance legislation, that came into effect in July 2012, the European Medicines Agency (EMA) released an initial list of drugs subject to additional monitoring on 25 April 2013. Please click here to read the full EMA Press Release, which contains additional information. How to identify them? Medicines subject to additional monitoring will have to display an inverted back triangle in their package leaflet and in the information for healthcare (...)

How to prepare and review summaries of product characteristics (SmPCs)

On 21 January 2013 the European Medicines Agency (EMA) published on its website a guidance document for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. EMA’s guidance (as highlighted in their press release below) consists of a set of presentations detailing the information that should be included in each of the sections of the SmPC, together with background information on SmPCs both as a presentation and a video. (...)

Court of Auditors issues tough criticisims of EU agencies for Conflicts of Interests

In early October, a report by the EU Court of Auditors on conflicts of interests in EU agencies found that they “are not managing conflict of interest situations appropriately”. This follows last years’ decision from the European Parliament to postpone the budgetary discharges for two agencies over management of conflicts of interest. The report audited policies of four agencies - the European Aviation Safety Agency (EASA), the European Chemicals Agency (ECHA), the (...)

The European Medicines Agency launches website on new European database of suspected adverse drug reaction

The European Medicines Agency (EMA) launched last May 31st the new European database of suspected adverse drug reaction reports website. The launch of this website is a positive first step in the implementation of the EudraVigilance access policy. The information carried on the site relates to approximately 650 medicines and active substances authorised through the centralised procedure. Within a year the EMA aims to additionally publish suspected side-effect reports for common drug (...)

EMA reflection paper discusses globalisation of clinical trials

The European Medicines Agency (EMA) has published the final reflection paper on ethical and good clinical practice aspects of clinical trials of medicinal products for human use. Conducted outside of the EU/EEA and submitted in marketing authorisation, it produced several applications to the EU regulatory authorities. Entering into force on 1 May 2012, the EMA reflection paper aims to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials (...)

Greater cooperation between European Medicines Agency and European Food Safety Authority

The European Medicines Agency (EMA, based in London) and the European Food Safety Authority (EFSA, based in Parma) have signed a memorandum of understanding setting out their commitment to fostering cooperation on areas of common interest. The agreement aims to ensure that both agencies make best use of their resources while avoiding duplication of effort in their activities. The EMA and the EFSA wish to develop scientific excellence and optimise risk assessment activities across the (...)

European Medicines Agency 2009 financial accounts blocked by the European Parliament

Due to transparency reasons, such as procurement, conflicts of interests and other concerns the European Parliament voted to block the 2009 accounts of the European Medicines Agency. The European Parliament’s budgetary control blocked the 2009 Discharge of the European Medicines Agency (EMA). The approval of the discharge’ is the Parliamentary check to authorize accounts for the EU institutions and how their budgets are implemented in a financial year. MEPs also raised (...)