SDA to Speed Up the New Drug R&D: Clinical Trials Can be Conducted within 60 Days without being Negated or Questioned

The State Drug Administration of China (SDA) has recently released the Announcement on Adjusting the Review and Approval Procedures for Drug Clinical Trials which mentions that in order to encourage the drug innovation in China, corresponding adjustments are made in connection with the review and approval of drug clinical trials in China, namely, any drug clinical trial that is applied for in China may be conducted according to the submitted protocol if it is not negated or questioned within 60 days from the acceptance and payment date. The markedly acceleration of the new drug development in China in recent years has not only benefited from the steady improvement of China’s drug R&D strength, but also from China’s policy support for new drug innovation and development. This adjustment of the review and approval procedures for drug clinical trials will undoubtedly open a green channel for the new drug development in China, with extensive and far-reaching significance.

Seen from the announcement, the review and approval system of drug clinical trials has the following characteristics after adjustment:

I.     The communication meeting to guarantee the smooth implementation of each link

According to the announcement, the applicant should file the application for communication meeting with the Center for Drug Evaluation, CFDA (CDE) before the application for the first clinical trial of the new drug, and CDE will decide whether to hold the communication meeting. The said meeting will involve the clinical trial protocol or draft, existing pharmaceutical and non-clinical study data, and other study data, etc., and will be chaired by staff of CDE, with relevant minutes of meeting archived. And the minutes will be used for reference in the review and approval.

We can see from the above that the communication meeting is in fact a process for the pharmaceutical product review and approval personnel to learn about the relevant drug, through which, review and approval personnel will have an overall initial grasp of the value and safety of the clinical trial to conduct. It is the "cornerstone" of each subsequent review and approval link of the relevant drug.

II.    The approval work to be "more pragmatic"

 "Pragmatic" is the biggest characteristic of the review and approval system of drug clinical trials after the adjustment. The announcement explicitly mentions that after an applicant files the clinical trial application, CDE will complete review within 5 days, and issue the notice of acceptance if the application meets requirements, with the notice stating that: the applicant may conduct the clinical trial according to the submitted protocol if it does not receive the negation or question of the CDE within 60 days from the acceptance and payment date.

Such approval for clinical trial if no negation or question is received within 60 days from the acceptance and payment date as mentioned above is the latest decision and is generally considered to be quite a "feel-good factor" to the drug clinical process by the industry. To put it simply, in this way, the "strength" of drugs researched by the new drug R&D units will be more focused on, and the next step of clinical trial may be smoothly implemented so long as the drug applied for is good in every index, and there is no problem with the data so that the CDE personnel do not have question. Moreover, the 60-day requirement gives the CDE a time limit and the applying enterprises a schedule to follow, which will be more conductive to the pharmaceutical enterprises’ conduct of the work that follows.

III.  Requirements to be "more explicit"

We can see from the announcement and the data attached therewith that the SDA has "more explicit" requirements for the review and approval of new drug clinical trials than before, which will facilitate pharmaceutical enterprises to conduct work as required and avoid detours. I’d like to underline some key points for you here. SDA makes it clear that it will focus on the followings in relation to the Phase I clinical trial application data of new drugs: 1. The integrity, scientificity and operability of the clinical trial protocols; 2. The sufficiency of the supportive research data; 3. The communication situation before the application; 4. Safety risk control of subjects; 5. Stakeholders of clinical trials.

Summary

This announcement involves the drug regulator’s reform of review and approval of Phase I-III clinical trials. Overall, it is to minimize pharmaceutical enterprises’ time and application efforts in conducting clinical trials on the basis of making sure of the safety and meaningfulness of new drug clinical trials. In recent years as China steadily improves its new drug R&D strength, the reform of the review and approval system will undoubtedly open a "green channel" for the potential new drugs developed in China in recent years, and, besides promoting those new drugs to be used to treat patients ASAP, will encourage and speed up the overall R&D of new drugs in China.

http://cnda.cfda.gov.cn/WS04/CL2111/329716.html?from=timeline&isappinstalled=0

Reference (extended reading):

http://cnda.cfda.gov.cn/WS04/CL2111/329716.html?from=timeline&isappinstalled=0

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