Attitudes and opinions towards regulatory aspects of non-prescription medicines
Attitudes and opinions towards regulatory aspects of non-prescription medicines
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DOI：
10.1081/crp-120018736
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发表时间：
2003-01-01
期刊：
影响因子：
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通讯作者：
Rhodes, CT
中科院分区：
文献类型：
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作者：
Achanta, AS;Temkin, CW;Rhodes, CT
本调查的第一部分制定并描述了FDA通过管理电子调查问卷提出的问题的定量答案。这一部分的目的是通过与美国、加拿大、联合王国和澳大利亚的主要舆论领袖进行电话访谈，从质量上进一步探讨这些问题。本研究旨在扩展早期的努力，并获得对上述问题的更多见解，并探讨了来自美国，英国，澳大利亚和加拿大的OTC药品监管领域的36位关键意见领袖和利益相关者的意见。结果表明，美国监管框架的潜在改进可能包括创建一个中间体，药剂师控制的OTC药物类别，在指导文件中描述数据要求以支持转换申请，根据当前OTC上市前安全性和有效性证明标准对非传统药物（膳食补充剂和营养保健品）进行监管，以及制定全球OTC专论。答复显示，支持监管机构单方面转换药品，此类决定仅基于总体公共卫生利益考虑。
The first part of this investigation developed and described quantitative answers to questions that FDA has posed through the administration of an electronic survey questionnaire. The goal of this part was to qualitatively probe these issues further by conducting telephone interviews with key opinion leaders in the United States, Canada, the United Kingdom and Australia. This study aimed to extend the earlier effort and gain additional insight into issues described above and explored the opinions of thirty six key opinion leaders and stakeholders in the area of OTC medicines regulation from the United States, United Kingdom, Australia, and Canada. Results suggest that potential improvements to the US regulatory framework can include creation of an intermediate, pharmacist-controlled class of OTC medicines, delineation of data requirements in a guidance document to support a switch petition, regulation of nontraditional medicines (dietary supplements and nutraceuticals) also as per current OTC standards of premarket demonstration of safety and efficacy, and, the development of global OTC monographs. Responses showed support for regulatory agencies to unilaterally switch drug products and such decisions to be based only on the overall public health benefit considerations.