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China FDA looks to trim review time for clinical trial applications

The China Food and Drug Administration is aiming to cut the time it takes to review clinical trial applications to just 30 days.

Speaking at Hong Kong Exchanges & Clearing Ltd.'s inaugural biotech summit, Ruyi He, chief scientist of the China Food and Drug Administration, or CFDA, Center for Drug Evaluation, said the most common complaint the agency receives is the lengthy approval time for investigational new drug applications.

China's protracted drug approval process had long frustrated multinational pharmaceutical companies who sought to bring innovative products into the Chinese market. New drugs launched overseas typically saw a time lag of five years or more before they could launch in China.

The progress the government is making in reforming its healthcare system is changing that.

"The government is determined to solve this issue," He said.

In October 2017, the CFDA updated its Drug Administration Law and introduced a review time of 60 working days. The legislation aimed to spur drug innovation and further streamline the approval process.

According to He, the drug evaluation process now includes a self-recognition system. A manufacturer can proceed with initiating a clinical trial 60 days after submitting the application if it does not hear from the agency.

If in 60 days a "no" is not given that means it is a "yes," which means that the enterprise can carry out the clinical trial, the official said.

To further improve the speed and efficiency of the drug approval process, the regulator wants to eventually be able to review clinical trial applications within 30 days like the U.S. FDA, he added.

To accomplish this, He said manufacturers must work closely with the CFDA to ensure that the quality of the data at the time of the filing — including data on pharmacology and toxicity from animal studies — is sufficient to support their clinical trial proposals.

He also highlighted the significance of China joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in speeding up the drug approval process.

More commonly known as ICH, the organization promotes the standardization of medicine quality to ensure safe and effective use. China became a member in June 2017.

As a member of the ICH, manufacturers who have filed a clinical trial application under the ICH guidelines in a member country will not need to repeat the process for China because its requirements will become standardized with the organization, said He, noting that this will reduce the repetition of processes, speeding up approvals and benefiting patients.

The CFDA is also looking to double its workforce to meet the needs of the government, going from about 800 employees to up to 1,600 by 2020, He said.