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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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6 International Applications of Regulatory Science
Pages 51-56

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From page 51...
... Michael Brennan, Senior Advisor for Global Affairs, Aeras Global TB Vaccine Foundation, presented an update on regulatory science needs to develop drugs for neglected diseases that affect primarily developing countries.
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From page 52...
... The proposed new paradigm calls for progressively authorizing increased indications for a drug as knowledge and investment increase. Through iterative phases of information gathering followed by regulatory evaluation and action, progressive authorization seeks to align regulatory decision making with emerging information on benefits and risks.
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From page 53...
... Ongoing efforts include one aimed at integrating more effectiveness data into the European Public Assessment Reports that EMA issues every time regulators take an action for a drug. Another pilot effort involves creating parallel scientific advisory committees in conjunction with health technology assessment bodies.
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From page 54...
... FDA has also released guidance documents for sponsors who are developing drugs and vaccines for global illnesses: • In September 2008, FDA issued a document entitled "General Prin ciples for the Development of Vaccines to Protect Against Global Infectious Diseases," which stated that FDA can license vaccines to protect against infectious diseases or conditions not endemic in the United States.3 • The agency has prepared a new document, "Guidance for Industry Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment and Prevention," that was released in draft 2 This section is based on the presentation by Michael Brennan, Senior Advisor for Global Affairs, Aeras Global TB Vaccine Foundation. 3 For more information, see http://www.fda.gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/Guidances/Vaccines/ucm074762.htm (accessed November 28, 2011)
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From page 55...
... . to meet standards for approval." Because many countries base their approvals on actions taken by the United States or the European Union, actions such as these could have powerful effects in poorer countries, said Brennan.
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Key Terms

  • health technology
  • assessment bodies
  • global neglected
  • neglected diseases
  • clinical trials

  • aeras global
  • regulatory decision
  • tropical diseases
  • senior advisor
  • neglected tropical

  • developing world
  • approval pathway
  • affect primarily
  • michael brennan
  • drug development

  • global affairs
  • vaccine foundation
  • drug developers
  • global regulatory
  • approval standards

  • tory science
  • time regulators
  • gressive approval
  • marketing authorization
  • objective criteria

  • iterative phases
  • regulatory arena
  • exchange programs
  • tax global
  • sive reduction


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