International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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5 Characteristics of Harmonized Regulations and Regulatory Structures
5 Characteristics of Harmonized Regulations and Regulatory Structures
Pages 49-56
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From page 49... ...
is engaged in ongoing efforts to align its radiation protection regulations with international recommendations, said Cindy Flannery, Senior Health Physicist, Office of Federal and State Materials and Environmental Management Programs, NRC. Much has changed with respect to the amounts of radiation people are exposed to from multiple sources, and scientific knowledge regarding the health harms of radiation because the standards on which U.S.
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From page 50... ...
• Develop the Final Rule -- The final language of the rule is published in a Federal Register notice, which includes a "comment resolution" section providing responses to all the comments on the proposed rule. In a real-life example, said Flannery, in 2007 the independent International Commission on Radiological Protection announced revised recommendations related to preventing radiation-induced diseases.
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For example, staff recommended that NRC update the method required for calculating radiation dose exposures to align with international recommendations, and the commission approved proceeding with this potential change. By contrast, staff recommended reducing occupational dose limits from 5 rem (Roentgen equivalent man)
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The benefits of regulatory alignment Flannery described are • establishing coherence within NRC regulations and updating them to a common basis; • reflecting a more current estimate of radiation risk and advances in scientific knowledge; and • consistency with the regulatory schemes of other countries. REFLECTIONS ON THE EXPERIENCES OF WHO3 WHO is the directing and coordinating authority on international health within the UN system, and it is therefore owned by the UN's 193 member states.
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From page 53... ...
For example, its good manufacturing practices standard for active pharmaceutical ingredients has become a common standard used by many countries. Rägo suggested that another important harmonization activity is WHO's project on International Nonproprietary Names.
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From page 54... ...
Several workshop participants underscored the importance of harmonizing the functional networks, while in the meantime strengthening the capacity of the smaller countries, in order to facilitate their eventual full participation in one or more networks. Rägo asserted that countries engaged in successful harmonization initiatives typically have a number of characteristics, including • an enabling environment and a strong foundation, including effec tive governance principles -- transparency and accountability -- and modern legal systems that allow certain flexibilities; • political will and a common vision; • socioeconomic development similar to that of other participating countries; • well-functioning regulatory authorities that have the necessary capacity and resources; • willingness to invest in harmonization and commit to implement ing, updating, and revising guidelines; and • use of good regulatory practice principles when implementing harmonized guidelines.
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From page 55... ...
Another trend Rägo noted is to use staff exchanges to promote harmonization and improve regulatory reviews. These exchanges help staff understand other regulators' thinking about the decision-making process.
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From page 56... ...
National decisions have to be made regarding which areas to focus on, where to build capacity, and in which areas to rely on other regulators' work," Rägo said. If smaller countries aspire to creating regulatory systems akin to those of Europe, the United States, or Japan, the resultant overload of work will delay their people's access to valuable biomedical products.
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