China Raises The Bar On Generic TCM Quality
This article was originally published in PharmAsia News
China recently revised the registration and approval regulation for generic traditional Chinese medicine (TCM), raising the quality bar for manufacturers and producers. It demands more specific details such as the TCM source, produce area and technology parameters, so as to ensure product standards and consistency. In addition, the regulation requires generic TCM to adhere closely to the original branded products in prescription composition, basic ingredients, production processes and technology parameters. Analysts note that the stricter regulations will encourage innovation and spur the development of the local industry. (Click here for more)
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.