T***i
发帖数: 281 | | T***i
发帖数: 281 | 2 "Substantial equivalence does not function as a scientific basis for the
application of a safety standard, but rather as a decision procedure for
facilitating the passage of new products, GE and non-GE, through the
regulatory process"—Royal Society of Canada[16]
看样子，加拿大皇家协会跟欧洲人一样土，属于那种‘’骗着骗着，自己当成真的了‘
’。要不就是有些人真的在骗人，自做聪明。 | k**********i
发帖数: 8706 | 3 这个是医疗仪器/医药领域的“等效产品”的概念，为的是帮助同性同质的产品加快上市的速度，相对于“新产品/新药”那种更为审慎的审查，时间大大缩短
21 CFR Section 807.100
FDA will determine that a device is substantially equivalent to a predicate
device using the following criteria:
(1) The device has the same intended use as the predicate device; and
(2) The device:
(i) Has the same technological characteristics as the predicate device; or
(ii)(A) Has different technological characteristics, such as a significant
change in the materials, design, energy source, or other | T***i
发帖数: 281 | 4 Monsanto给自己的转基因种子也用的这个概念，其实就是为了加快审批过程呗，
换言之，
这玩意要严格审批，过不了。
上市的速度，相对于“新产品/新药”那种
更为审慎的审查，时间大大缩短
predicate
【在 k**********i 的大作中提到】
: 这个是医疗仪器/医药领域的“等效产品”的概念，为的是帮助同性同质的产品加快上市的速度，相对于“新产品/新药”那种更为审慎的审查，时间大大缩短
: 21 CFR Section 807.100
: FDA will determine that a device is substantially equivalent to a predicate
: device using the following criteria:
: (1) The device has the same intended use as the predicate device; and
: (2) The device:
: (i) Has the same technological characteristics as the predicate device; or
: (ii)(A) Has different technological characteristics, such as a significant
: change in the materials, design, energy source, or other
| T***i
发帖数: 281 | 5 治疗感冒头疼，吃阿斯匹林也行，吃999速效胶囊也行，这个算substantially
equivalent没问题。
转基因食品是不是几十年后让人因为癌症死翘翘，谁也说不准副作用有啥，所以才搞这个猫腻。 |
|
