SFDA To Speed Up Evaluation Of Registered Drugs
This article was originally published in PharmAsia News
Executive Summary
To solve the problem of evaluating a huge backlog of registered drugs, China's State FDA has begun a centralized drug evaluation strategy since January to handle approved but overdue applications before the revised Drug Registration Regulation becomes effective. The new approach is divided into two stages: January to April 2008 was the data comparison stage where SFDA sieved out registration applications with similar information, content or fabricated data to ensure authenticity; April to September 2008 is the technical evaluation stage where experts meet to adopt centralized review techniques and methods in new drug development. (Click here for more - Chinese Language)You may also be interested in...
Japan's BioComo Pursues Novel Ligand Approach To Immuno-Oncology
Japan bioventure BioComo was set up around 10 years ago and has since been honing its technology platform. It is now preparing to move into the clinic with a novel vector for immuno-oncology and to raise new funds to support pipeline development.
China Uses Old To Fight New As Repurposed Drugs Take Coronavirus Role
Several newly repurposed drugs, including a Bayer antimalarial, have shown potential benefits against the new coronavirus, promoting China to add several to its latest revised treatment guidelines.
US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports