• 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...
  • Report: FDA Increasingly Playing Key Role in Global Health

    A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders. The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D,...
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    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...
  • FDA Report: Agency Moving to Engage Globally to Meet Realities of Supply Chain

    The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a new report that aims to show how the regulatory agency is revamping itself from a domestic agency to one with a "global public health focus". "As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world," said Hamburg in a statement. FDA's Global Engageme...
  • China: Device Testing and Globalization of Trade

    China must gradually establish an international device regulatory philosophy to adapt strategy to the globalization of trade, according to SFDA Commissioner Yin Li, who spoke at the medical device testing conference held in Zhuhai 10-11 April 2012. Li added that the medical device testing institutions are an important force in the medical device regulatory system, and have played a huge role in the development of China's device industry.  Attendees included: th...
  • China: Healthcare Reform Opportunity To Strengthen Regulation

    The National Bureau of Policy and Regulation Department's Liu Pei said on 12 April 2012 at a national food and drug regulation conference that health care reform provides an opportunity to strengthen the supervision and regulation of essential drugs. He also noted the importance of the global environment and its role in national food and drug policies and regulations. For 2012, the food and drug policies will include strengthening supervision over law enforcement an...
  • Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

    An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...