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 Issues New Guidelines On Phase I Trials – Will It Speed Up Approvals?

This article was originally published in PharmAsia News

Executive Summary

The clinical trial process has become a bottleneck for licensing new drugs in China. Now, China’s State FDA has stepped up with a new guideline for Phase I clinical trials– will it help speed up the process?

You may also be interested in...



China Builds Up Capability To Conduct Oncology First-In-Man Studies

SHANGHAI - Oncology clinical site operator South Texas Accelerated Research Therapeutics (START) is partnering with Fudan University Shanghai Cancer Center (FUSCC) and Cenova Venture Fund to open an oncology site in Shanghai to provide early-phase clinical services in China to support the many global and domestic pharma and biotech companies that are investing in more projects to target China's oncology market

Reforms In China's Center For Drug Evaluation Designed To Boost Innovation - DIA China Conference

BEIJING - Ongoing reforms in China's drug review body are attracting the attention of the pharma industry, which is hoping the changes will result in a faster drug review process. During the third annual DIA China meeting in Beijing, officials from China's Center for Drug Evaluation unveiled more details of the reform and reaffirmed that the ultimate goals are to improve quality and drive efficiency of drug reviews

China's Center For Drug Evaluation Remakes Itself To Enter New Era Of Transparency, Speed Up Approvals

SHANGHAI - For years, China has talked about revising its drug review system to improve efficiency, and now major changes are in the works with China's State FDA reforming its drug review body, the Center for Drug Evaluation, to encourage drug innovation and facilitate globalization of its drug review process

Topics

Related Companies

UsernamePublicRestriction

Register

SC079451

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