EMA

As negotiations between the UK and the remaining 27 members of the European Union commence in the next month or so, questions of trade, IP protection and of free movement will emerge.

Wherever the EMA winds up after Brexit, the reality for anyone working on drug development is that the strains and constraints of their job are not going to get any easier.

Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?

Europe is issuing a significant update to its ethical guidelines governing health-related research involving humans.

With bidding starting to intensify among member states, several factors will determine the EMA’s next home.

The European Medicines Agency’s new website of detailed information on products it has assessed has been launched. Thus begins a new era of open access data for European pharma industry professionals.

The European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union. Peter O’Donnell reports on his experience accessing this database.

New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.

With registries gaining steam as a potential European policy agenda, the EMA plans to incorporate them into the healthcare community. This movement aims to solve the issues of getting the right drugs to the right patients at the right time, and at something like the right cost.

A look at the EMA’s proposed guidance revisions for first-in-human studies.

While Europe is feeling the effects of the recent UK Brexit vote, the European Medicines Agency is continuing onward with business as usual despite questions over its location and the future of its employees.

European consumers are concerned that faster drug development processes being pushed by regulators can be unsafe for patients. With the EMA spearheading discussion on medicines adaptive pathways to patients, or MAPPs, more convincing is needed.

Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.

Peter O'Donnell writes that the EMA surprisingly diverted from it's usually strict boundaries on it's annual report published in May.

New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.

Hans-Georg Eichler, the Senior Medical Officer at the European Medicines Agency, addresses adaptive pathways as a way to "ensure sustainability of the innovation system and the healthcare systems."

This week, The Netherlands, which is in charge of EU business for the first six months of this year, has convoked an intensive round of meetings to show that it really is taking health policy seriously during its turn in the rotating EU presidency.

European health officials and patient advocates speak bluntly on the treatment access dilemmas for patients with rare diseases-and point to opportunities in translational research and joint negotiations with manufacturers as possible solutions to close gap.

Incoherencies in Europe’s drug-access arrangements raise questions, debate.

Although only the beginning of an exploratory process, the EMA is being accused of colluding in a conspiracy to favor drug firms at the expense of patient protection.

EMA board announces the new clinical trial rules have shifted still further away, and is now October 2018.

Despite orphan-drug R&D and approval being all the rage, issues such as patient access could leave these treatments out in the rain.

Several initiatives are focused on integrating biomarkers and personalized medicine techniques into studies.

Officials tackle such areas as early diagnosis and treatment, patient access, and personalized medicine

The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe

The European Union's extensive transatlantic links have reached a further level of maturity with the completion at the end of 2014 of exchanges between the European Medicines Agency and Health Canada.

It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014.

A new call for proposals is going to appear in December from the Innovative Medicines Initiative, the European Union partnership with the pharmaceutical industry.

The annual worldwide antibiotic awareness event--celebrated in Europe on November 15--generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers.