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  • Regulatory NewsRegulatory News

    European Parliament Calls for Rapid Relocation of EMA Headquarters

    The European Parliament on Wednesday called for an agreement to be reached “as quickly as possible” to relocate the headquarters of the European Medicines Agency (EMA) following the UK’s decision to exit the EU. The question of where to relocate the nearly 900 EMA staffers from London (EMA has already said member states will decide ) will not be an easy one, particularly as virtually every member state has requested to be the new home for the agency. Ireland, Croatia, ...
  • Regulatory NewsRegulatory News

    EMA's 2015 Annual Report: Interest in Scientific Advice Increasing

    The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year. According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled , leaving the agency without a head until November of the following year when Rasi was re-appointed . Despite the disruption to EMA's le...
  • Regulatory NewsRegulatory News

    A Second Chance? EMA Board Nominates Guido Rasi to Lead Again

    The European Medicines Agency’s (EMA’s) Management Board on Thursday nominated Professor Guido Rasi as the executive director of the agency, a little less than a year after he was forced to step down from the position. Rasi has been invited to give a statement to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on 13 October 2015, and the appointment of the new executive director will be made after this session. The EMA told ...
  • Regulatory NewsRegulatory News

    EMA Scrambles to Consider Options After Leader Ousted

    Members of the European Medicines Agency (EMA) met last week to consider an unprecedented question: How should they select a new, permanent leader after they were forced to fire the last one? Background On 13 November 2014, the EU Civil Service Tribunal found that Guido Rasi, then EMA's executive director of three years, had been appointed through an improper selection process and that his appointment would be annulled. At the time, a seemingly stunned EMA said ...
  • Regulatory NewsRegulatory News

    EMA Re-Elects Former MHRA Regulator to Lead Influential Management Board

    The European Medicines Agency (EMA) has announced the re-election of Sir Kent Woods as the chair of its influential 35-member Management Board, which sets regulatory policies for the agency. Woods, who served as chief executive at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) between 2004 and 2013 , will now serve as the board's chair for a final three-year term, after which time term limits preclude him from running again. Woods said in ...
  • EMA Looks Back on a Tough Year as it Forges Ahead

    Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst...
  • MHRA: Patients With Metal-on-Metal Hips Need Extensive Monitoring

    The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the lifetime of the device. Previous advice by MHRA has only advised patients and surgeons to monitor the device for 5 years after the device was implanted. "This updated advice is based on updated evidence that patients with hip replacements with head diameter of 36 millimetres or...
  • UK Regulator: Don't Overreact to PIP Scandal

    The head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese scandal . In remarks made at a press conference on 16 February, Woods called for "better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators," wrote Reuters . Woods added that while he t...