CFDA strengthens the administration of registration and transfer of injection and other products, and the power is returned to the General Administration

Source: asidak news agency, Dec 11, 2014, big wisdom news agency learned from CFDA that from Jan 1, next year, the right to review and approve the technology transfer of sterile drugs such as injection will be returned to CFDA, and the provincial drug regulatory agencies that have been approved and authorized by CFDA will also stop this work CFDA said that since January 1, 2015 Since, the application for technology transfer registration of sterile drugs such as injections shall be submitted for supplementary application in accordance with the procedures and requirements of the provisions on the administration of the registration of technology transfer of drugs, which shall be reviewed and approved by the State Food and drug administration; the provincial drug regulatory authorities that have been authorized by the General Administration shall stop accepting the application for technology transfer registration of sterile drugs such as injections; and the application has been accepted The application for registration of shall be carefully reviewed with respect to process verification, quality comparison and other research materials If it does not meet the requirements, it shall not be approved In February 2013, CFDA issued the notice on matters related to the transfer of pharmaceutical technology in the process of implementing the newly revised pharmaceutical production quality management specifications, which stipulates the transfer of pharmaceutical technology involved in the overall relocation and merger of traditional Chinese medicine enterprises in the process of GMP transformation, and authorizes the provincial pharmaceutical supervision department to manage Among them, sterile drug manufacturers such as injection shall apply for transfer registration before December 31, 2014 This time, after this time node, CFDA will return the power to the general administration.