Transition period for record-filing of clinical trial institutions for medical devices, 24 November
CFDA issued a Circular on Effectively Working on the Record-filing of Clinical Trial Institutions for Medical Devices on 24 November 2017. It sets a one-year transition period from 1 January 2018 to 31 December 2018. During this period, sponsors can continue to operate clinical trials by cooperating with clinical trial institutions designated by CFDA. After the period, sponsors shall cooperate with the recorded institutions.
CFDA & NHFPC clarify the regime for recorded clinical trials institutions of medical devices, 15 November
CFDA and National Health and Family Planning Commission (“NHFPC”) jointly issued the Measures for Conditions Met by Institutions for Clinical Trials for Medical Devices and Administration of Record-filing of Eligible Institutions (“Measures”) on 15 November 2017, which will come into effec on 1 January 2018. It clarifies the qualification and proceedings for the regime of recording clinical trial institutions of medical devices. Applicants are required to fill in necessary information and submit relevant documents, including their self-examination reports and certificates etc. A file number will be given to the applicant which allows it to conduct clinical trials.
CFDA regulates online drug sales, 10 November
CFDA issued a draft of the Measures for the Supervision and Administration of Selling Drugs Online (“Draft”) on 10 November 2017, which is open for public comments until 30 November. Qualified sellers shall conduct their business within the approved scope. They should also equip themselves with necessary IT systems and a qualified distribution system. The Draft also clarifies the online platform provider’s obligation of supervising the sellers, protecting data and privacy, and recalling products.
CFDA regulates false promotion of health food, 9 November
CFDA issued a Circular on Implementing Plan of Rectification of Fraudulent and False Publicity Campaigns on Food and Dietary Supplements (“Circular”) on 9 November 2017. It highlights four kinds of fraudulent conduct: 1) un-licenced business operation 2) False representations, particularly medical-related representations; 3) False labelling; and 4) un-approved advertising. The Circular also clarifies the legal responsibility of the third party, such as the online food trading platform provider.
CFDA seeks comments on the registration and recording of health food, 3 November
China Food and Drug Administration (“CFDA”) issued the Amendments on Administrative Measures for the Registration and Recording of Health Food (Draft for Comment) (“Draft”)on 3 November 2017. The draft relaxes the timeline to renew the registration certificate for health food. Applicants shall file the renewal application before the expiry date of the certificate. CFDA will approve the application within 6 months. If the date expires while the approval is pending, manufacture shall be suspended until the renewal is approved.