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On November 19th, CDE's official website issued the Notice on the Release of the Third Batch of Clinically UrgentLy Needed New Drugs Abroad.
In accordance with the Bulletin on The Clinical Urgent Need for Review and Approval of New Drugs Abroad (No. 79 of 2018), the State Drug Administration and the National Health and Safety Commission organized the relevant expert research and demonstration, selected the third batch of clinically urgent need for new drugs from abroad, including Cablivi and other 7 varieties.
, CDE on the third batch of clinical urgent need for foreign new drugs list to be published (relevant reading: the third batch of clinical urgent need for foreign new drugs list publicity involving Astellas, Yan Jian, Yan Yeyi ... ）。
notice shows that the varieties included in the list of new drugs in clinical urgent need abroad may submit relevant information in accordance with the Procedures for the Review and Approval of New Drugs In ClinicalLy Needed Overseas, and apply directly for listing, and our center shall establish a special channel to speed up the review.
not yet declared varieties, can at any time put forward with my center to communicate and exchange, as soon as possible to apply for listing.
to this point, the State Drug Administration, together with the National Health and Safety Commission, has organized a full selection of varieties that meet the requirements of the Bulletin on the Clinical Urgent Need for Review and Approval of New Drugs Abroad (No. 79 of 2018), which basically solves the urgent clinical needs. The historical legacy of the slow listing of new drugs listed overseas in China, and with the deepening of the reform of the review and approval system and the transformation and implementation of the ICH guiding principles, China has gradually established a legal system for the simultaneous research and development declaration of new drugs from abroad, and encouraged the simultaneous development and declaration of new drugs from abroad in China.
