1
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The purpose of this short talk I am going 
to show you some of the regulatory differences 
between the tobacco environment or the nicotine 
environment and the pharmaceutical drug development. 
在这个视频中，我将给大家简单介绍一下尼古丁在烟草和药品研发之间的一些应用监管差异。

2
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The safety assessment regulations for new 
medicines have been in place for many years 
and have proved largely effective in protecting 
patients from harmful new drugs. 新药安全性评价规定已实施多年，事实证明，该规定在保护患者免受有害新药危害方面基本有效。

3
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The pathway for the evaluation is well-defined 
and the studies required and the appropriate 
study designs are covered by OECD and ICH 
guidelines. 经合组织和国际化学品管理局的指南对评价的途径进行了明确的界定，所需的研究和适当的研究设计都已涵盖。

4
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The regulations for the approval of tobacco 
products on the other hand are relatively 
new and evolving. 另一方面，烟草制品的审批条例是比较新的，也在不断发展。

5
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At the moment, large numbers of PMTA dossiers 
have been submitted of differing quality 
and the outcome of those submissions has 
yet to be determined. 目前，已经提交了大量质量参差不齐的PMTA申请，而这些申请的结果尚未确定。

6
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In addition, medical products are brought 
to market to address a particular unmet medical 
need or to provide a more efficacious or 
a safer product to patients, so the rate 
of introduction to market is very much lower. 
Hundreds of products per year rather than 
tens of thousands for ends devices and e-liquids. 
此外，医疗产品推向市场是为了解决某一特定的未被满足的医疗需求，或为患者提供更有效或更安全的产品，因此其上市率相较而言比较低。每年几百种产品，而不是几万种终端设备与电子液体。

7
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The development time for a new medical product 
is likely to be a region of seven to ten 
years, but the time to introduce an ends 
product market is much lower and the weight 
of evidence required to achieve regulatory 
approval is somewhat less. 开发一种新的医疗产品可能需要7到10年左右，但引入终端产品市场的时间要低得多，获得监管部门批准所需的证据权重也要低一些。

8
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Medical product legislations have been harmonized 
worldwide through mutually recognized ICH 
guidelines which ensure that quality medicines 
can be brought to patients more quickly and 
it is not necessary to repeat clinical and 
toxicology programs for each country. This 
is not yet the case for tobacco legislation 
and different requirements and standards 
exist around the world, so typically we would 
undertake saftey assessments for one market 
and then have to do additional work to satisfy 
new markets requirements. 由于医疗产品已经通过相互认可的ICH指南在全球范围内得到统一，这确保了高质量的药品可以更快地送到患者手中，免去了在每个国家重复进行临床和毒理学实验才能上市的要求。但目前世界各地对烟草产品仍有不同的要求和标准，所以通常我们会对一个市场进行安全评估，然后还要做额外的工作来满足新市场的要求。

9
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Another major difference between tobacco 
products and medicines is the complexity 
of the ingredients and the degradant profile. 
For a medical product, the core ingredient 
is often highly pharmacologically active 
but the formulations are selected as simple 
as possible and there are minimal degradation 
products. This is very different for tobacco 
products which use natural tobacco leaf which 
has a complex ingredient profile and flavoring 
based on natural product and has many thermal 
and non-thermal degradants, so the toxic 
assessment covers many more chemicals than 
that for a medical product.  烟草制品与药品的另一大区别是成分的复杂性和降解产物。对于药用品来说，核心成分往往具有很强的药理活性，但配方会尽可能地进行简化，降解产物极少。另一方面，使用天然烟叶的烟草制品成分更加复杂，而且有很多热降解与非热降解产物，所以毒性评估中需要涵盖的化学成分测算要比医药产品多很多。

10
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In the development of the medical product, 
the non-clinical and clinical programs run 
in parallel and are closely linked so that 
any adverse events in animal species are 
explored and prevented by careful dose selection 
in humans. In tobacco products, much of this 
work is done through desk-based toxicology 
and the clinical program is comparatively 
light relying mostly on pre-case studies 
and behavioral studies as pharmacological 
effect of nicotine are already well characterized.