SYDNEY, Australia, Oct. 30, 2022 (GLOBE NEWSWIRE) — Novotech, Asia Pacific’s leading biotech specialist CRO, and GlobalData have released the latest analysis of China’s biotech landscape, with expert guidance on pathways to USFDA approval for biotechs, doing research in China.
The report has been prepared for international biotechs considering China for their clinical research, Chinese biotechs conducting research in China and the relevant processes required for USFDA approvals.
Novotech’s Vice President, Global Head of Clinical Services, Dr. Yooni Kim said:
“China offers exceptional clinical opportunity with vast populations and world-class research facilities and KOLs. This concise analysis of the path to USFDA approval expertly briefs clinical-stage biotechs on the benefits of Chinese research and how to address any challenges.”
The report describes the regulatory requirements for biotechs, including NDA and IND processes, as well as ex-US research guidance for a successful USFDA approval pathway.
With experienced clinical teams in China and the US, Novotech can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the USFDA approval process and avoid delays and additional costs.”
The key findings from the report are:
- Companies should contact the USFDA early and formally to confirm guidance for their clinical roadmap.
- China’s clinical development regulations are aligned with USFDA regulations and offer significant advantages for biopharmaceutical companies.
- Biopharmaceutical companies should take advantage of China’s revised regulatory framework for accepting foreign clinical trial data for drug approval to facilitate foreign companies’ entry into the Chinese market.
- For biopharmaceutical companies looking to enter China, China’s pharmaceutical market offers advantages such as conducting first-in-human (FIH) trials and utilizing overseas clinical trial data for clinical trials…
