• Regulatory NewsRegulatory News

    European Regulators Drawn Into Debate on Drug Pricing

    Although drug regulators aren’t supposed to be concerned with pricing when making decisions on products’ safety and efficacy, they’re increasingly being drawn into what two representatives of the European Medicines Agency (EMA) and the heads of two national regulators call an “acrimonious debate” over drug costs. In a New England Journal of Medicine editorial published Thursday, EMA’s Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Exe...
  • Regulatory NewsRegulatory News

    European Drug Prices: New Commission Report on What Policies Work and What Could Work

    The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check. The 260-page report on drug pricing in Europe, released Thursday by the European Commission, looks into two policy options: external price referencing (EPR), which is predominantly a tool for medicine price control and currently employed across the region, and differ...
  • New Transparency Standards Now in Place for EMA's Management Board

    The European Medicines Agency (EMA) is on a transparency kick. After coming under unrelenting pressure from the European Parliament (EP) and other stakeholders over perceived opaqueness at the agency, EMA has recently moved to roll out a number of initiatives it says it hopes will reverse the notion that it is a closed agency. Now, its transparency efforts are going right to the top. In an announcement made 8 June, EMA said its Management Board will now be subject to...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...