Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips
Executive Summary
Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.
You may also be interested in...
New Modalities Help Chinese Biotechs Win Investors’ Attention
Five Chinese bioventures have raised more than $70m from venture capital and private equity funds since late May.
Drought Ending? Shanghai’s STAR Market Considers Two IPO Applicants
With the first half of 2022 ending, two Chinese developers of innovative drugs - antibody specialist Chongqing Genrix Biopharmaceutical and Suzhou Teligene, which focuses on small molecules, are looking to go public on Shanghai’s STAR Market, ending a recent drought of biopharma listings.
China Tweaks On-Site Inspection Priorities As Registration Filings Soar
China’s Center for Drug Evaluation has introduced a risk-based process to initiate on-site inspections related to drug registrations. It is hoped the novel system will suit the current capacity of auditor teams against a backdrop of an ongoing spike in product approval applications in the country since 2019.