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On December 1, the State Food and Drug Administration issued the "Guidelines for the Registration and Review of Non-original Companion Diagnostic Reagents for Antitumor Drugs", "Guidelines for the Registration and Review of Data from Overseas Clinical Trials Using In Vitro Diagnostic Reagents" and "Neural and Cardiovascular Surgical Devices" -Guiding Principles for the Registration and Review of Knives, Scissors and Needles
details as follows:
Announcement of the State Food and Drug Administration on the issuance of two registration review guidelines including clinical trials of non-original companion diagnostic reagents for anti-tumor drugs
Announcement of the State Food and Drug Administration on the issuance of two registration review guidelines including clinical trials of non-original companion diagnostic reagents for anti-tumor drugs(No.
(No.
Appendix:
1.
Guidelines for the registration and review of clinical trials of non-original companion diagnostic reagents for anti-tumor drugs
2.
Guidelines for the registration review of overseas clinical trial data using in vitro diagnostic reagents
Announcement of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration and Review of Nerve and Cardiovascular Surgical Instruments-Knives, Scissors and Needles (No.
Announcement of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration and Review of Nerve and Cardiovascular Surgical Instruments-Knives, Scissors and Needles (No.
Attachment: Nerve and Cardiovascular Surgical Instruments-Guidelines for Registration and Review of Knives, Scissors and Needles
Nerve and Cardiovascular Surgical Instruments-Guiding Principles for Registration and Review of Knives, Scissors and Needles
