International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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2 Principles and Definitional Considerations
2 Principles and Definitional Considerations
Pages 13-22
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From page 13... ...
THE TERMINOLOGY LANDSCAPE AND OPTIONS FOR REGULATORS1 Mike Ward, Manager, International Programs, Health Canada, began his presentation by emphasizing that the lack of commonly accepted definitions in drug regulation is a stumbling block to harmonization. Lack of clarity exists, he said, even around such deceptively obvious concepts as regulatory cooperation.
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From page 14... ...
Putting these albeit imprecise notions together, Ward suggested that a working definition of international regulatory cooperation could be "intercountry activities carried out with a view to improving national regulatory outcomes and promoting convergence." The current lack of common understandings can lead to confusion and, more important, can set unrealistic or varying expectations in the minds of central agencies, regulators, industries, consumers, and other stakeholders. This working definition could involve any number of countries, is applicable at all stages of the regulatory life cycle, from assessment of new or existing regulations through program implementation, and, finally, to review and evaluate regulatory programs.
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From page 15... ...
Perhaps most relevant in the current context, said Ward, is the WTO Sanitary and Phytosanitary Agreement related to food safety and animal and plant health. It defines harmonization as "the establishment, recognition and application of common sanitary and phytosanitary measures by different members (jurisdictions)
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From page 16... ...
Ward noted that the Pan American Network for Drug Regulatory Harmonization (PANDRH) , established to promote pharmaceutical regulatory harmonization and capacity building within the Americas, recognized at the outset that asymmetries within the regulatory capacities of the hemisphere's nations might impede implementation.
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From page 17... ...
The pharmaceutical industry is a global business, and these varying rules cause delays, impede access to needed medicines, and increase the costs of health care. Unless different standards have some scientific justification, they are both medically and ethically suspect, according to Carolyn Compton, President and Chief Executive Officer, Critical Path Institute (C-Path)
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From page 18... ...
• Methods standards cover topics like the use of disease models, clini cal trial simulation tools, and in vitro models. 3 Global good standards have been achieved in many other industries.
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From page 19... ...
Once approved, the new standard can be used by any company to develop drugs with the assurance that the scientific basis of their data collection will be acceptable to these regulators. C-Path organizes its standards development collaborations into consortiums that are generally focused on a single disease process or on a methodology, such as the generation of patient-reported outcomes instruments.
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From page 20... ...
At FDA, the extreme variability and unpredictability of data format and content present major obstacles to performing timely, consistent, and efficient data reviews, said Compton, which ultimately hamper innovation. In order for FDA staff to work efficiently, they need standardized and well-organized data, they need to understand the basis of the data collection, and they need to understand the scientific basis on which those data were collected.
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From page 21... ...
PRINCIPLES AND DEFINITIONAL CONSIDERATIONS 21 one regulatory system in one country may not require the same yardstick needed in another. Some greater effort to measure the true extent of harmonization would reveal whether only some aspects of drug regulation are harmonizing or converging, while others -- and perhaps the whole international system -- are becoming more divergent.
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