Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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The CDFA & the Chinese Pharmaceutical Industry

The CDFA & the Chinese Pharmaceutical Industry

China is currently recognized as the world's second-largest pharmaceutical industry. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies. Some of the reasons for those...

CFDA:中国医药监管的未来与机会

中国食品药品监督管理局(CFDA)成立于2013年。原来称作“国家食品药品监督管理局”(State Food and Drug Administration,简称SFDA),后改名为“国家食品药品监督管理总局”(China Food and Drug Administration,简称CFDA),将多个监管机构合并为食品和药物安全的唯一监管机构。

China Announces Change to Clinical Trial Requirements

China Announces Change to Clinical Trial Requirements

Earlier this week, China's State Council announced plans to allow clinical trial data from other countries. As one of the largest pharmaceutical markets in the world, they are looking to bring in new, innovative therapies quicker. This comes on the heels of changes...

Medical Device Quality and ISO 13485:2016 Certification

Published in 2016, ISO 13485:2016 is in its third edition. ISO 13485:2016 comes on the heels of the ISO 13485:2003. Beginning in March 2016, there is a three-year transition period which comes to an end on February 28th 2019. These regulatory requirements undergo...

Man vs Machine Translation: The Continued Debate

Quite a while ago we took a look at the role of machine translation (MT) in life science translations. It's a hot topic of debate, and we can all see with a quick internet-based translation what the pitfalls are. These one-off quick translations of a block of text...