HomeNews Clinical Research Opportunities in China and the Path to USFDA Approval

Clinical Research Opportunities in China and the Path to USFDA Approval

by admin
Clinical Research Opportunities in China and the Path to USFDA Approval

SYDNEY, AU, Oct 25, 2022 – (ACN Newswire) – 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.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

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.

About Novotech

Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: [email protected]
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Topic: Press release summary

Source: Novotech Health Holdings Pte Ltd

Sectors: BioTech, Healthcare & Pharm, Clinical Trials


From the Asia Corporate News Network

Copyright © 2022 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

Source : ACN Newswire

You may also like

Clinical Research Opportunities in China and the Path to USFDA Approvalhttps://www.aljomhoor.net  https://www.intelli.news/  https://dedalustats.com  https://www.magasinjouet.net  https://www.passionerestaurant.com/  
Premier League Community: How Everton maintain mental health in the local community * Marketing Briefing: Coca-Cola and other major marketers enter ‘test and learn’ phase with generative AI * Le Fasting – La méthode de jeûne intermittent ultra efficace pour perdre du poids et vivre longtemps *  *-*Les eMOS antenne coaxial blindé Droit mâle sD3010 10 m * Tunisia cuts off water supply at night amid severe drought * Lillet Blanc Aperitif a Base Vin, 17% vol, 750ml *  -*-https://www.passionerestaurant.com/  https://jeuxjouetsremise.com  https://vinsdivins.fr  https://www.deguiseo.com  https://www.lecordonniermalchausse.fr/  https://www.intelli.news/  https://pushkarvisit.com  https://www.puzzlee.org/  Clinical Research Opportunities in China and the Path to USFDA Approval*Clinical Research Opportunities in China and the Path to USFDA Approval

news7.asia Clinical Research Opportunities in China and the Path to USFDA Approval