EMA

The European Commission has concluded exploratory talks, with Moderna, over the purchase of a fifth potential vaccine against COVID-19.

The European Commission has concluded exploratory talks, with Moderna, over the purchase of a fifth potential vaccine against COVID-19.

Europe is aiming to improve its medium-term planning for citizens' health with an agenda that aims to "enable and leverage research and innovation in regulatory science."

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing.

The search for a coronavirus vaccine is just one of many questions unanswered on European health policy.

The balance is being sought in Europe data governance between private protection and public benefit-but has not yet been achieved.

Europe’s additional monitoring scheme hasn't been a roaring success, according to a recent report.

Peter O'Donnell writes of the European Commission's recently published reports suggesting that some of the gaps were being filled in registries in the field of rare diseases.

New money is not going to solve problems when it comes to registries in Europe, Peter O'Donnell writes.

Peter O'Donnell writes about Manfred Weber's announcement of what he called "his European Master Plan against Cancer" – with what he termed "a guarantee" for European citizens, taking political lobbying over health to a new level in Europe

After taking a long awaited step forward in a rare treatment, the impatience of European patient organizations are understandable given the slow emergence of advanced medicines. Peter O'Donnell writes there is good news for patients - just not quite as good as they may have thought.

Discussions on collaborative health technology assessment have been so intense over the last year that it might be thought that Brussels is the hub for HTA action. Peter O'Donnell writes how there is plenty going on elsewhere in Europe.

Regulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.

Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.

Insights into the implementation of IDMP in the EU.

Peter O’Donnell explores the convergence of policy and science in new vaccine R&D pursuits in Europe.

Peter O'Donnell discusses the EU's bid to improve the HTA and weighs in on a report made by Soledad Cabezón's.

Peter O’Donnell weighs the varying views in Europe on the risks of going the adaptive pathways route for drug approval.

Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.

With the literal toss of a coin officially sending the EMA to Amsterdam post-Brexit, it's worth reflecting on what might have been if the decision went differently.

As concerns grow about the slow progress of advanced therapies, drug developers are pushing for action from European authorities.

New safety review of epilespy treatment puts spotlight on issues such as communication between regulators and prescribers.

The EMA isn't mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. It has been stated that "the future of public health in Europe is at stake" and this decision will make or break it.

This article outlines the EMA's response from a previous blog by Peter O'Donnell regarding the potential of Milan, Italy as the EMA relocation.

What cannot have escaped the attention of any impartial observer is that Milan is one of the leading contenders to host the EMA and that Tajani and Rasi are both Italian. The EMA relocation is a hot topic without any bias towards Milan.

Of the 28 European Union member states, nine did not make an offer to host the European Medicines Agency (EMA) by the July 31 deadline-and one of them is very sorely missed, writes Peter O'Donnell.

The European Health Data Network (EHDN) initiative kicks off-a challenging and resource-intensive effort designed to harmonize data analysis and conversion amid the push toward outcomes-focused healthcare in Europe.

Peter O'Donnell discusses the interest expressed by members states to host the EMA.

Several projects in works illustrate the importance of those unsung heroes in Europe's R&D engine room.

Nearly every EU member country has put in a bid to host the EMA once the UK leaves the European Union in 2019. The conditions and criteria for doing so are now becoming clear.