China Cuts Drug Approval Timelines, Sets Tough Penalties On Individuals Violating R&D Or Safety Rules
Executive Summary
Newly released registration proposals signal the Chinese regulator’s intent to foster an environment that is conductive to innovation. Expedited new drug approvals alongside strict control over quality are key elements of these proposals.
You may also be interested in...
China Proposes Norms For Conditional Approval, Compassionate Use
Two new proposals by the China FDA will likely accelerate regulatory approvals of novel treatments for life-threatening and rare conditions in the country. By allowing foreign study data, these proposed norms are expected to prompt international drug makers to engage with local regulators early in their global new drug development process.
Homegrown China Oral Antiviral Shows Early Promise
Junshi’s oral antiviral shows signs of effectiveness in treating patients with mild COVID-19 symptoms but more data are needed, caution researchers.
China Takes A Bigger Role In The World Pharma Stage
2021 saw a record number of novel drug launches and the size of the pipeline topped 20,000 candidates for the first time, new analysis shows, while China came of age as a pharma player.