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What revolutionary changes the new draft for comment of CFDA on clinical trials will bring?

What revolutionary changes the new draft for comment of CFDA on clinical trials will bring?

by en-cphi.cn

June 2, 2017

CFDA issued the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) at midnight of May 11 to solicit comments from the society.

Announcement of the CFDA on Seeking Public Comments on Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) (2017 No. 53)

Issued on May 11, 2017

To further intensify the reform of the review and approval system, promote the structural adjustment of and technological innovations in the pharmaceutical product and medical device industry, enhance the industry competitiveness, and meet the clinical needs of the general public, China Food and Drug Administration has consulted with relevant departments of the State Council and drafted the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment) and is now soliciting comments on this Draft from the society. Comments concerning revisions are suggested to be sent by e-mail to CFDA’s Department of Drug and Cosmetics Registration by May 25, 2017. The deadline for the submission of comments is June 10, 2017.

Any content in the Draft involving amendments to laws and regulations will be handled in accordance with the relevant procedures.

This announcement is hereby issued.

Annex: Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment)

There are mainly 7 pieces of information in this Draft. Next, I will interpret them piece by piece to explain in detail what revolutionary changes these policies will bring to the clinical trial field.

  • Change clinical trial institution qualification recognition to filing management. The main content is: Cancel the qualification recognition of clinical trial institutions. After registration and filing on the websites designated by the food and drug regulator, all medical institutions with clinical trial conditions can accept applicants’ entrustment to conduct clinical trials. Social capital is encouraged to be invested in the establishment of clinical trial institutions to provide professional clinical trial services.

    Interpretation: In my opinion, the tension of the clinical trial resources can be relieved after implementation of the filing management.

    The qualification recognition method has been adopted for the clinical trial institutions in China all this time, with the recognition procedure generally divided into three steps, separately being: acceptance of qualification recognition, onsite inspection for qualification recognition, and review and announcement on qualification recognition, being quite tedious and troublesome.

    Procedure and flow of qualification recognition of clinical trial institutions are as follows:


     

  • There have been only about 475 clinical drug trial institutions that obtain the qualification recognition of CFDA so far, and they are mainly 3A-grade hospitals.

    Article 2: Support investigators and clinical trial institutions in carrying out clinical trials. The main content is: Conditions and capabilities for clinical trials shall be incorporated as a key indicator for the level appraisal of medical institutions and the determination of key clinical disciplines; a separate evaluation and examination system shall be established for medical institutions conducting drug clinical trials. Hospital beds used only for clinical trials shall not be counted in the total number of hospital beds in such medical institutions, and the benefit, turnover rate and utilization rate of hospital beds, etc. shall not be specified as evaluation indicators. Medical personnel who conduct clinical trials shall be treated equally with clinicians in post promotion an...

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