China Cuts Drug Approval Timelines, Sets Tough Penalties On Individuals Violating R&D Or Safety Rules
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...
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.
Which drug candidates represent hope, and which hype? The Scrip team examine the COVID-19 pipeline, lessons from China, and some long term impacts on the sector.
China insists there is no double standard and won’t tolerate any quality issues in its centralized procurement process.