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.
China VBP, Localization And Other Strategies - How Far And Which Way?
Could health sector players encounter issues similar to those facing Tesla in China, a country which virtually saved the electric vehicle maker but where it is now facing challenges? Are there any lessons to be learned from a success story under China's volume-based procurement scheme? A partner at EY looks at these and other issues.
Medtechs Must Reflect On China Localization Policies As VBP Expands
China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.