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Beijing Further Strengthens Industry Supervision to Regulate Stem Cell Clinical Research
From:Beijing Municipal Commission of Health and Family Planning
Date:08/09/2017

        

Recently Beijing Municipal Commission of Health and Family Planning, Beijing Food and Drug Administration jointly printed and distributed the Implementation Opinions on Further Strengthening Supervision on Stem Cell Clinical Researches in Medical Institutions in Beijing (hereinafter referred to as the “Opinions”). The Opinions state that in the Beijing administrative region, except the clearly specified hematopoietic stem cell transplantation without in vitro treatment and stem cell clinical trials filed as medicine, stem cell treatment technology shall be managed as clinical research. The institutions that intend to conduct stem cell clinical research shall fulfill the institution filing and project filing procedures in accordance with the Regulations on Stem Cell Clinical Trials (For Trial Implementation). The clinical research project conducted shall comply with the applicable scope of the filing institution and the results achieved after the completion of the clinical research shall not be directly put into clinical applications.

The Opinions propose the establishment of Beijing Stem Cell Clinical Research Management Work Leading Group responsible for carrying out national management requirements for stem cell clinical research and guiding and supervising the stem cell clinical research in Beijing. The Expert Committee on Stem Cell Clinical Research shall further play its role in providing advice for management decisions and making policy recommendations. The stem cell clinical research expert bank will be established in Beijing to conduct the initial technical review of the institution and project filings in relation to stem cell clinical research and participate in the supervision and check on filed stem cell clinical research institutions and projects.

The Opinions clearly stipulate on institution and project filing procedures and conditions and responsibilities for institution filing, the means and ways for submitting filing materials, the review procedures to be conducted by Beijing Municipal Commission of Health and Family Planning and Beijing Food and Drug Administration, and the filing procedures that shall be fulfilled by institutions already filed by the Commission and Administration before conducting the project.

The Opinions stressed that the filing institution is the responsibility body for the management of stem cell preparations and clinical research quality. The institution shall establish institution leading group, improve the academic committee and the ethics committee, constantly enhance internal management system and do a good job in stem cell quality control and management.

In addition, a steering group shall be set up to conduct regular inspections, random checks and causative checks on filing institutions and filing projects. Those institutions which violate the regulations on stem cell clinical research shall be punished accordingly.