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...
EU Pushes For Compulsory Licensing Of Drugs & Vaccines In Health Crises
The EU has published an action plan that is intended to upgrade the bloc’s intellectual property framework while ensuring that goods such as medicines and vaccines are made as widely available as possible. The initiative is part of wide-ranging plans to support member states’ recovery from the pandemic crisis and help ensure the EU’s resilience to future health threats.
Execs On The Move: New CEO For Humacyte; Internal Moves At Trinity Biotech, CVRx, Oventus Medical And Cancer Genetics
Trinity Biotech's new CFO is an internal move; Humacyte replaces CEO; chief strategy officer role for former CVRx CFO; and more.
Teva Slapped With €60m Fine Over Unlawful EU Provigil Delay
Teva received a “package of commercial side-deals” for agreeing to halt generic competition to Cephalon’s Provigil (modafinil) throughout the EU, which it “would not have achieved without committing to staying out of the market,” according to findings by the European Commission.
Need a specific report? 1000+ reports available
Buy Reports