• 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 ...
  • RAPS' LatestRAPS' Latest

    An Individual’s Experience at the RAPS Executive Development Program

    Regulatory leaders need to deliver strategic value to their organizations—the RAPS Executive Development Program is a key component in building the necessary skill set to succeed. According to the RAPS 2014 Scope of Practice , the vast majority of individuals entering the regulatory profession hold scientific or engineering roles and only 14% of regulatory professionals have a business background. Considering this lack of experience, bridging the gap between regulator...
  • Regulatory NewsRegulatory News

    Indian Parliament Proposes Extending Price Caps to all Drugs

    Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...
  • 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

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • Regulatory NewsRegulatory News

    Digging Deeper into China's New Medical Device Registration Requirements

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA  Administrative Order No. 4  covers new and revised requirements for Class I, II and III device registrations in China that will take effec...
  • Feature ArticlesFeature Articles

    China’s Order 650 and its Impact on Medical Device Regulation

    After recent State Council reforms, the China Food and Drug Administration (CFDA) became the singular authority on medical device supervision. On 31 March 2014, the Chinese government finally released Order 650 (former Order 276), Regulations for the Supervision and Administration of Medical Devices. The order, effective 1 June 2014, sets the fundamental framework and orientation on medical device supervision and administration in China. Eighty articles determine ...
  • New Executive Order Directs Agencies to Identify and Reduce 'Regulatory Burdens'

    • 10 May 2012
    The White House has released a new executive order directing federal agencies to identify and reduce "regulatory burdens" in their respective organizations, noting the "challenging economic times" the US is traversing. President Barack Obama's executive order, "Identifying and Reducing Regulatory Burdens", builds upon an existing order by the president ordering agencies to periodically review existing significant regulations and find efficiencies within them. Obama's st...
  • Obama Signs Order Promoting International Regulatory Cooperation

    US President Barack Obama signed a new Executive Order on 1 May that the White House hopes will promote international regulatory harmonization and reduce costly misalignments that stifle "economic growth, innovation, competitiveness and job creation." "In an increasingly global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting" a least-burdensome approach to regulatio...
  • Group: Industry Lobbying Tarnishing FDA Integrity

    The science advocacy group Union of Concerned Scientists (USC) is lambasting what it claims is excessive industry pressure on the US Food and Drug Administration (FDA), and claims the pharmaceutical, medical device and biotechnology sectors spent a combined $700 million between 2009 and 2011 to lobby legislative and executive officials. "Pharmaceuticals companies and related trade groups spent more than $487 million on lobbying over this three-year period, while biotechn...
  • FDA, Other Agencies Asked to Consider 'Cumulative' Impact of Regulations

    The Office of Information and Regulatory Affairs (OIRA), the federal agency tasked with overseeing and approving all regulations in the US, sent notice to all federal agencies this week calling on them to "take account of the cumulative effects of new and existing rules." In a letter dated 20 March, OIRA Administrator Cass Sunstein noted the effects of regulations on companies, and asked federal agencies to take steps to "reduce redundant, overlapping, and inconsistent r...
  • New Insurance Product Covers Exposure to Health Fraud Cases

    • 05 March 2012
    Worried about your exposure to healthcare fraud? A new product is looking to protect employees at pharmaceutical, biotech and medical device companies-among others-that are worried about being the subject of health fraud investigation and subsequent action under the Park Doctrine, writes the Philadelphia Inquirer. The Park Doctrine holds that executives who fail to act in accordance with their responsibilities can be held personally responsible for fraud perpetrated ...