• Tonio Borg Likely Replacement for European Commission's Dalli

    It's official: Tonio Borg has been nominated as the successor to EU Health Commissioner John Dalli , who resigned last month after a scandal involving his agency's treatment of pending tobacco legislation, and will appear before EU legislators in several days for a hearing. Under European Commission (EC) rules, the replacement to a relinquished post must go to a person from the same country. Borg, a native of Malta like Dalli, currently serves as the country's deputy pr...
  • EU Health Commissioner John Dalli Forced out in Wake of Fraud Probe

    The EU's Health Commissioner, John Dalli, has resigned from the European Commission (EC) following an investigation into his handling of a review of a policy on tobacco-the latest black mark for EU health regulators who have seen a number of high-profile scandals and resignations in the past two years. In the press statement , the EC said Dalli's resignation followed a complaint made by Swedish Match, a tobacco manufacturer which claimed Dalli had traded favors with a M...
  • EMA to Allow Biosimilar Applications to Reference Data from Products Approved Outside EU

    The European Medicines Agency (EMA) has announced its intent to accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA), allowing companies an alternate and potentially easier route to obtain approval for new biosimilar products in the EU. Biosimilars, also known as follow-on biologics or similar biological medicines, are highly similar versions of already-approved biologics medicines. Unlike generic pharmaceutical products, which...
  • Report: New EU Clinical Trials Regulations to Come As Early as Next Week

    • 10 July 2012
    European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July 2012, reports Reuters . The legislation, previewed at a 27 June meeting in Washington, DC, is in response to what Dalli referred to as a "decline in clinical research in the EU." The EU has seen a 25% decline in the number of clinical trials conducted in the EU between 2007 and 2011, though Dalli hedged that the decline was not exclusive...
  • EC's Dalli Proposes New EU Clinical Trials Legislation

    The European Commissioner for Health and Consumers, John Dalli, has announced his intent to propose new legislation to govern clinical trials conducted in the EU. Appearing at a 27 June 2012 meeting in Washington, DC hosted by the European American Business Council, Dali said he is "committed to putting forward a legislative proposal with the aim of strengthening knowledge and innovation in clinical research." Dalli said in his opinion, "[the] future procedure for the a...
  • Dalli: Commission Looking to Overhaul Clinical Trials Directive

    John Dalli, the European commissioner for health and consumer policy, spoke 7 March about the need to review and modernize the Clinical Trials Directive before a joint event put on by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Roche Group. "This debate comes at a very good time - the Commission will come forward with a proposal to revise the Clinical Trials Directive later this year," said Dalli. Dalli noted clinical trials hav...
  • EC's John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

    The European Commission's (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to "look at the sector of medical devices as a whole," saying that both the EC and national agencies need to review how medical devices are approved in the EU in a speech given to the press on 9 February . "As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had i...