Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

China FDA Expands Clinical Data Witch Hunt To CROs, Study Sites

This article was originally published in PharmAsia News

Executive Summary

Drug manufacturers in China were firstly required to conduct self-audits of the clinical data submitted to support their product approval applications, then clinical sites were asked to improve study oversight. Now, contract research organizations seem to have become the latest target as the China FDA expands a crackdown on clinical data forgery in which it seemingly considers a 20% failure rate not sufficient.

You may also be interested in...



China-US Divide Deepens On Covid Vaccines, Azar Taiwan Visit

China has shown willingness to go tit-for-tat in its bilateral disputes with the US and the latest comments from US officials show an underlying distrust over clinical data and vaccines safety in China, raising fresh concerns just when collaboration is needed to accelerate availability of the first vaccines in the global pandemic.

China Braces As Trump Orders 'Buy American' For Essential Medicines

As the largest manufacturer of active pharmaceutical ingredients globally, China is bracing for more uncertainty amid the global pandemic and fast-changing environment, particularly in the US.

China Still Alluring? AZ, Pfizer Feel COVID Pinch, New Pricing Scheme Clouds Outlook

Despite leading multinational pharma firms including AstraZeneca again delivering double-digit growth in China, the impact of coronavirus and an expanding volume-based purchasing scheme begin to surface.

Topics

UsernamePublicRestriction

Register

LL1130496

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel