China FDA changes will speed up approval process, says CRO

By Flora Southey

- Last updated on GMT

Four new draft policies were released May 11. (Image: iStock/Golden_Brown)
Four new draft policies were released May 11. (Image: iStock/Golden_Brown)
Proposed changes to drug, medical device and clinical testing regulations provide stimulus for conducting trials in China, says CRO George Clinical.

The contract research organisation’s (CRO) managing director, Philip Gregory, said the China Food and Drug Administration’s (CFDA) four new draft policies​ (in Chinese), released May 11, herald an exciting new era for drug and device development.

“If implemented in full, these proposed changes will standardise regulatory requirements, allow for greater use of foreign data broadening eligibility of sites to conduct trials, provide greater transparency of the ethics processes, and ultimately shorten approval timelines,” ​he said.

According to the China-based director, the policies support investigators and clinical testing organisations to carry out clinical trials, improve the clinical trial review process, accept overseas clinical trial data, and support exploratory clinical research, which, if approved, will make the CFDA regulations comparable with other major global players.

The proposed changes show a “proactive response by a regulatory body keen to improve the overall drug development process and make new medicines available faster for the Chinese population,” ​he said.

The draft policies – open for public comment until June 10 – highlight Chinese regulators’ continued commitment to improving access to medicines.

The CFDA released proposed changes​ to drug trial and API importation laws on March 17 to shorten clinical trials and approval times to meet “public demand for new drugs.” 

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