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By Lynn Yao

四月 03, 2020

随着医药科技不断发展和进步,中国的药品审评标准在不断改变和提高,过去的药品审评标准没有强制要求仿制药与原研药质量和疗效一致,所以有些药品在质量、疗效上与原研药存在一定差距,需要改进提高。自2015年开始,国家药品监督管理局(原国家食品药品监督管理总局)推出仿制药质量和疗效一致性评价,借以提高我国仿制药的质量和疗效。质量和疗效视为等同于原研产品的仿制药将在公立医院的招标和处方中享受优先待遇。

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By Fran DeGrazio

一月 17, 2020

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.

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By Fran DeGrazio

一月 14, 2020

ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.