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  • Regulatory NewsRegulatory News

    WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

    A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...
  • Regulatory NewsRegulatory News

    PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has elected Paul Hargreaves of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as its new chairman for 2016 and 2017. Hargreaves, elected at a meeting in Indonesia last month, will be the fourth PIC/S chairman from the UK and he will follow the departure of Joey Gouws, acting head of South Africa’s Medicines Control Council, who was the first PIC/S chairperson from Africa.   Following the succe...
  • Regulatory NewsRegulatory News

    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...
  • Regulators: Need to Pay More Attention to Regulatory Capacity of Developing World

    • 24 October 2012
    Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the US Food and Drug Administration (FDA) in the latest issue of the Public Library of Science Medicine (PLoS Medicine) . The article, Strengthening Medical Product Regulation in Low- and Middle-Income Countries , was authored by Charles Preston, Mary Lou Valdez and Katherin...
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    Regulatory Professionals, Top Regulators From Around the World to Converge in Seattle for 2012 RAPS

    In a few weeks, 2012 RAPS: The Regulatory Convergence will bring approximately 70 healthcare regulators and some 2,000 total attendees from around the world to Seattle. The regulatory officials scheduled to speak represent national and international agencies overseeing health products, including 36 speakers from the US Food and Drug Administration (FDA), as well as representatives from agencies in Europe, China, Japan, India, Brazil, Canada and more. The Regulatory Conv...
  • Brazilian Regulators Go On Strike

    Brazilian government officials, including those at the regulatory agency Anvisa, have gone on strike, leaving the agency critically under-staffed and scrambling to make sure its basic operational functions are maintained. Anivsa said in a statement that the Brazilian Supreme Court has ordered it to ensure at least 30% of its work force remains on the job during a  strike of the regulatory agency's workers . Anvisa has reportedly assured industry that the agency...
  • With Regulatory Risks High, Companies Purchasing Higher Insurance Limits for Corporate Officers

    • 16 March 2012
    Companies concerned about their corporate officers' exposure to regulatory claims are purchasing ever-higher limits on existing insurance policies, reports The Wall Street Journal ( WSJ ). Many insurance policies do not cover the cost of legal settlements for regulatory claims, which leaves many of the top brass at companies exposed to "a highly litigious environment," according to one source interviewed by the WSJ . "The policies, generally called "D&O liability...
  • Hamburg: Development of Regulators 'Critically Important'

    Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), spoke at length to The Washington Post about her leadership style at FDA, the development of regulatory professionals and career growth for regulators at FDA. Hamburg said she fully supports FDA staff in their intellectual and scientific work, and is "making sure our employees have career development pathways, ongoing education, as well as engagement with the broader scientific community, whic...