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International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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7 Tactics and Strategies for a Way Forward
Pages 67-76

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From page 67...
... Hans V Hogerzeil, University of Groningen, the Netherlands, suggested that what can be learned from the several multinational networks discussed at the workshop -- such as ICH, PANDRH, APEC, and 1  The first panel consisted of chairs of the previous workshop sessions, as described ear lier; the second panel involved Deborah Autor, Deputy Commissioner, Global Regulatory Operations and Policy, FDA; Hans-Georg Eichler, Senior Medical Officer, EMA; and Alan Morrison, Vice President, International Regulatory Affairs and Safety, Amgen Inc.
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From page 68...
... Examples of these more focused activities mentioned by individual workshop participants include the following: • Harmonization with respect to pharmacovigilance is beginning to happen with the aggregation of postmarketing data and use of standard terminology (Deborah Autor, Deputy Commissioner, Global Regulatory Operations and Policy, FDA)
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From page 69...
... Often, lower-income countries are plagued with tainted, substandard, or fake medications, and if their regulatory agencies were helped to do a more effective job stemming the tide of illegal medicines, the size of the market for legitimate drugs would increase, and the population would not be exposed to worthless or hazardous products. Eichler said it is therefore not just good industrial policy to increase the efficiency and effectiveness of regulatory agencies; it is also good public health policy.
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From page 70...
... Governments are increasingly under pressure to figure out how to reduce the costs of regulation and avoid duplication of effort, said Galson, whether it occurs in regulatory tool development, clinical trials, amassing the evidence base, postmarketing safety, or manufacturing processes. What has to be avoided, said Chua, is the temptation of government leaders to assume that, because harmonization is expected to reduce regulatory costs, the workforce and budgets of regulatory agencies can be reduced immediately -- before harmonization is achieved.
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From page 71...
... With respect to antibiotics, for example, the lack of new products in the face of rising microbial resistance to existing treatments is an increasingly serious problem, he said. Similarly, Seiter added, the current incentive system does not well support development of innovative products related to the neglected tropical diseases (or orphan drugs in general)
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From page 72...
... Its Pathway to Global Products Safety and Quality 3 is built on the themes of forming global coalitions of regulators, developing global data systems, using advanced risk analytics, and leveraging the efforts of public and private third parties. Autor asserted these four fundamental ideas demonstrate FDA's recognition that it needs to work with others, rely on others' work, and create efficiencies.
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From page 73...
... . Workshop participants were divided on the issue of whether to wait until a thorough business case could be developed for harmonization or "just do it." The truth is probably somewhere in between, suggested Autor.
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From page 74...
... Performance assessment also is needed at the multinational network level. In some cases, going to a regional network may not actually save time in the approval process, but several workshop participants gave examples that review times have been substantially shorter than usual.
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From page 75...
... Risk management and risk mitigation strategies also could be harmonized, added one participant. The European Union, for example, has a risk management plan, and the United States uses a risk evaluation and mitigation strategy template.
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Key Terms

  • regulatory harmonization
  • global regulatory
  • clinical trials
  • opportunity costs
  • amgen inc

  • regulatory operations
  • regulatory affairs
  • european union
  • deputy commissioner
  • deborah autor

  • harmonized regulations
  • medical officer
  • alan morrison
  • senior medical
  • harmonization initiatives

  • regulatory costs
  • building regulatory
  • regulatory tool
  • regulatory environment
  • predictable regulatory

  • regulatory activities
  • provide regulatory
  • competing regulatory
  • regulatory strategy
  • regulatory issues

  • basic regulatory
  • reduce regulatory
  • diseases suggests
  • occurring simultaneously
  • initial steps


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