• EMA's Rasi Moves to Streamline Conflict of Interest Policies at EMA

    The European Medicines Agency (EMA) has released an updated procedure governing how the agency's employees are investigated for any potential conflicts of interest (COI) relative to their duties reviewing medicinal products. The standard operating procedure (SOP), Conducting checks for conflicts of interest of Agency employees assigned duties relating to medicinal products for human or veterinary use , was approved by EMA Executive Director Guido Rasi on 23 March 2012...
  • EMA Launches New Board to Coordinate Committees' Scientific Standards

    The European Medicines Agency (EMA) announced the launch of a new Scientific Coordination Board (SCB) which is intended to coordinate the development and implementation of standards between its committees. The board, which was announced 25 April, aims to make it "so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment," EMA said in a statemen...
  • EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised

    The European Medicines Agency (EMA) announced it is looking to develop a "way forward for publication of full clinical trial data" after concerns were published about selective publication of Tamiflu efficacy data. Tamiflu, which was stockpiled heavily around 2009 due to fears about swine flu, was recently attacked in the medical journal PLoS Medicine by authors Peter Doshi, Tom Jefferson and Chris Del Mar, who claim the drug overstated its effectiveness by hiding cert...
  • EMA's Rasi Seeks Greater Industry Participation

    European Medicines Agency (EMA) Executive Director Guido Rasi said in remarks at an industry conference he hopes to see greater industry involvement with EMA through stakeholder forums , reports Outsourcing Pharma . "The only stakeholder that is not now in the agency is the industry, but we do have a forum where we can discuss with them and include them," said Rasi to Outsourcing Pharma . "The time is now for a higher level of engagement," added Rasi. Martin Harvey,...
  • EMA Strengthens Conflict of Interest Policies

    The European Medicines Agency (EMA) announced Monday, 26 March its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. The Management Board also adopted several other initiatives, including a transparency initiative to "increase the transparency of all pharmacovigilance activities of the Agency and national authorities" while implementing the ...
  • EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination

    The European Commission (EC) will investigate whether or not to recommend regulating higher-risk medical devices such as pacemakers and implants differently than lower-risk medical devices, reports InPharm . Regulated medical devices in the EU and US are classified according to risk, with Class I devices representing the lowest probable risk, and Class III medical devices representing the highest probable risk. EC Health and Consumer Policy Spokesperson Frederic Vinc...
  • Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

    United Kingdom Health Secretary Andrew Lansley announced a new initiative aimed at "ensuring the safety of people seeking cosmetic interventions" on 11 January in response to the recent Poly Implant Prothese (PIP) breast implant crisis. Lansley announced that an expert review group led by National Health Service (NHS) Medical Director Professor Sir Bruce Keough will look at how NHS can better collect quality data on their devices, whether cosmetic products and interven...
  • EU to Unveil New Follow-on Biologic Guidelines in Late Q1

    European Medicines Agency Executive (EMA) Director Guido Rasi told Reuters on Friday that the agency plans to release final guidelines on follow-on biologics-also referred to as biosimilars or biogenerics-in March or April of 2012, with draft guidelines on the approval process to follow a month or two later. The initial guidelines will reportedly detail the requirements for copies of several types of biologic drugs. EMA has had a regulatory pathway for biosimilars f...