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  • 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 Appeals Decision That Ousted Former Executive Director

    The European Medicines Agency (EMA) is pressing forward with its plans to appeal a decision that annulled the appointment of its former executive director, Guido Rasi, Politico reports. Background On 13 November 2014, after hearing claims by Emil Hristov, who sought the executive director spot alongside Rasi in 2010, the EU Civil Service Tribunal ruled parts of the selection process were improper due to the composition of the pre-selection panel. During the hiring ...
  • 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's Top Drug Regulator, Guido Rasi, Forced to Step Down

    In a major development, the head of the European Medicines Agency (EMA), Guido Rasi, has been forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011. The case against Rasi's appointment was filed by Emil Hristov, formerly with the Bulgarian Drug Agency and a member of EMA's board, who maintained that EMA and the European Commission had improperly assembled a short list of candidates...
  • Regulatory NewsRegulatory News

    EMA Defends Changes to Trials Transparency Plan as Advocates go on Attack

    The European Medicines Agency (EMA) is defending its updated clinical trials transparency policy, now derided by some as ineffectual and contrary to its original aims, as being a "compromise approach" meant to placate concerns within industry that too much transparency would have had detrimental effects. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies we...
  • EMA: Opportunity Costs of Risk-Averse Approaches Must be Taken into Account by Regulators

    As those in the regulatory profession well know, there is a cost to action, and a cost to inaction. Performing an audit of a manufacturing plant might cost $200,000, but not conducting an audit could result in regulators finding previously unknown problems and shutting down a plant, costing tens of millions in lost revenue. The same is true for regulators. Approving a drug with notable side effects might harm patients, but not approving the same drug might deprive other ...
  • EMA Management Board Turns Focus to Regulatory Science and Faster Approvals

    In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to allow for drugs to get to patients more quickly and with a better understanding of patients' tolerance for risk-a potential boon for members of rare patient populations. In a statement, EMA said the board has already turned its attention-much as the US Food and Drug Administr...
  • World's Top Regulators Tackle Ethics of Pharmaceutical Innovation

    The heads of the world's two leading drug regulatory agencies, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, tackled the issue of regulatory ethics on a panel they shared with Nobel Laureate Professor Elie Wiesel at the 3rd annual Galien Foundation Forum in New York on 17 October. Both Hamburg and Rasi agreed that ethics is a matter of trust. In the regulatory environment, this ...
  • Auditors Hit EMA for Failing to Meet Conflict of Interest Standards

    • 12 October 2012
    Auditors with the European Court of Auditors (ECA) have determined that the European Medicines Agency (EMA), despite its attempts to increase transparency and implement conflict-of-interest (COI) policies, is falling short of its responsibilities to, "Adequately manage COI situations." "A number of shortcomings of varying degrees have been identified in Agency-specific policies and procedures as well as their implementation," ECA wrote. "After examining the situation...
  • EMA Report: Approval Numbers Likely to be Lower than 2011

    The European Medicines Agency (EMA) has released a mid-year report detailing its progress in 2012, showing a projected decline in the number of submitted applications even as products seeking orphan designations surged 30%. The report, highlighted in an EMA press release on 10 October, was originally reported to EMA's management board by Executive Director Guido Rasi. Rasi, who took over EMA this year after Thomas Lonngren stepped down in the midst of controversy, ha...
  • Continuing Transparency Push, EMA to Make all Meeting Minutes Public

    In a change with existing policies, the European Medicines Agency (EMA) announced Thursday, 19 July its plans to make all committee agendas and minutes publicly available by the end of 2013. The move is the latest in a flurry of recent moves by the agency to increase transparency after years of criticism regarding its perceived opaqueness. EMA coupled its announcement with a "first wave" of documents pertaining to the Paediatric Committee (PDCO) . The documents for that...
  • 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...