legacy products是指什么？

药窕淑女

如附件
这里的legacy product指的是什么啊。是指生产工艺进行到一半的产品吗？有点不理解，期待高手来解答一下。谢谢了

补充提问：
如果是老产品，必要时，应提交上市许可变更申报。这里的必要时，一般指什么时候需要申报呢

yuansoul

都是高科技啊。

245084691

是指老产品，工艺研发较早，不太符合新的法规要求。

药窕淑女

245084691 发表于 2015-4-20 16:15
是指老产品，工艺研发较早，不太符合新的法规要求。

谢谢了，原来是这个意思

gin

指老产品，很多有十几年到几十年历史的产品，依据当时的要求进行的研发和生产。

一沙一叶

同意，老产品

syhorchid

长见识了

beiwei5du

The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines on process validation (1, 2). These guidelines describe the steps required to ensure that a pharmaceutical manufacturing process is validated. The guidelines, however, are mostly aimed at new or recently developed products. Legacy products, which are products developed in the past but still exist on the market, are mentioned in section III (1) with reference to common traditional process validation methods (2), but without specific guidance on how to develop a validation study.

beiwei5du

This article provides a briefdescription of a stepwise approach for the manufacturing process transfer of alegacy product, using a combination of techniques (e.g., risk analysis toolsand a logical approach) wherever possible.