Clinical Research Opportunities in China and the Path to USFDA Approval - Whitepaper

Novotech, the leading Asia Pacific biotech specialist CRO, and GlobalData have published the latest China biotech landscape analysis with expert guidance on pathways to USFDA approval for biotechs conducting research in China.

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The report was prepared for international biotechs considering China for their clinical research, as well as China 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 presents exceptional clinical opportunities with vast populations and word-class research facilities and KOLs. This concise analysis of the pathway to USFDA approval expertly informs clinical stage biotechs about the China research benefits and how to manage any challenges.”

The report details the regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful USFDA approval pathway.

Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the USFDA approval process, avoiding delays and additional costs.”

The key learnings from the report are:

• Companies should engage with the USFDA early and formally to confirm guidance on their clinical roadmap.
• China’s clinical development regulations are aligned with the USFDA regulations and present significant benefits for biopharma companies.
• Biopharma companies should take advantage of China’s revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.
• For biopharma companies looking to enter China, China’s pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favorable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.
• Chinese biotech companies can enter developed markets in the US and Europe through strategic partnerships or by setting-up their own operations in these markets.

Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research.

The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award.

In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.