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China Attempts to Sift Through Backlog of Clinical Trial Marketing Applications

China Attempts to Sift Through Backlog of Clinical Trial Marketing Applications

For several years China has been experiencing a growing accumulation of pharmaceutical marketing requests and clinical trial applications. Factors contributing to this dilemma include improvements in research sparking new drug developments, modernizing standards to fall in line with the international community and a stricter regulatory process.

The Process

Unlike many other administrations elsewhere, such as in the USA, the Chinese Food and Drug Administration requires reviews to take place after each individual trial, regardless of the status of the drug in question, which tends to be rather time-consuming and tedious but thorough and effective. Each drug in question must be given permission to enter trials, at the end of which, assuming positive results, the drug may be put forward for certification.

The path through the system is the same for generic drugs as it is for new drugs, with no expedited pathway available in a system that also implements many redundancies which cause delays of their own. In fact, the average delay when just applying to register clinical trials is nearly 14 months per application.

The Fix

This was the case until recently, however. Much of the system is still in place, but some modifications to the overall programme have helped release some of the pressure from the delays. China has implemented a new coding system which grants a distinction in the system between drugs that are new and innovative and those that are generics or improvements on already existing medications. In order to accelerate modernizing their system, many terms have also been updated, such as innovative drugs being redefined to indicate they are internationally innovative instead of just within China.

Other changes are being made to the clinical trial approval system. These changes involve restructuring some elements of the trials and recording as well as encouraging more support from research centres and clinical trial assistants, such as those from, in order to streamline the process without compromising results.


All of these changes have led to a reduction in the backlog of applications without sacrificing the quality of their strict approach to approvals. The improved standards by which applications are being judged have also generated some breakthroughs on the international level, particularly those regarding cancer treatments. By both modernizing standards and streamlining the certification pipeline, the pharmaceutical community is strengthened.