On January 13th, the National Drug Administration issued the "Method of Change of Changes (Trial)" (Trial) "(Trial)" (Trial) "(Trial)") (hereinafter referred to as "Measures"), and the implementation of the implementation <post-market after listing (Trial)> Description "(hereinafter referred to as" Description "), to further strengthen the change management after the market is listed, and the" Measures "is successfully implemented.
"Description" requires that drug listing license holders (hereinafter referred to as holders) should fully study to ensure that drugs after changes are consistent with the quality and efficacy of primary drugs. Provincial drug regulatory authorities should strengthen the supervision of changes in drugs, especially to strengthen changes in the evaluation of drugs that have been evaluated by the quality and efficacy consistency of the hyperplasia. "Description" clear, "Measures" have been changed after the issuance of drugs, which has been accepted before the listing of drugs, can continue to handle according to the original procedures and related technical requirements; the holder can also take the initiative to withdraw the original application, according to the "Measures" Supplementation, filing or report. In order to avoid the impact of policy changes, the implementation of Article 10 of the "Measures" has a transition period.
"Description" proposed, the "Notice on Printing and Distributing the Registration Registration Management Registration of Drug Technology" (hereinafter referred to as "Notice" in the original State Food and Drug Administration (the original imported drug) is transferred by drug production technology The households can continue to study and declare additional applications in accordance with the "Notice" before January 15, 2023, and will be completed within the time limit. According to the "Notice" requirements, the national drug regulatory authorities completed the examination and approval within the specified time limit, and did not comply with the requirements or not approval as required by the requirements. According to the "Description", the holder has filed a record change in the "Drug Business Application System" through the National Food and Drug Administration drug registration network; the National Food and Drug Administration Drug Review Center and the provincial-level drug supervision departments are The reception of related materials is completed in the "Drug Business Application System".
Within 5 days from the date of completion of the filing, the official website of the State Food and Drug Administration will publicize the filing information.
The holder can query the filing information in the official website of the State Food and Drug Administration – "Medicine".