Medical Policies Weekly
1. The Center for Drug Evaluation issued the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Acute Non-Varicose Upper Gastrointestinal Bleeding"
On August 5, CDE issued the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Acute Non-Varicose Upper Gastrointestinal Bleeding", which will be implemented from the date of issuance. The guidelines are mainly for the treatment of upper gastrointestinal bleeding caused by gastric or duodenal ulcers. The treatment of acute non-varices upper gastrointestinal bleeding caused by other causes such as acute gastric mucosal lesions can also use it as a reference. The guidelines mainly discuss the key focus of clinical trial design in the research and development of peptic ulcer bleeding treatment drugs; it is suitable for the research and development of chemical drugs and therapeutic biological products.
2. The Center for Drug Evaluation issued the "Guidelines for Research on the Immunogenicity of Low Molecular Weight Heparin Generic Drugs (Trial)"
On August 6, CDE issued the " Guidelines for the Immunogenicity of Low Molecular Weight Heparin Generic Drugs (Trial)", which will be implemented from the date of issuance. Based on the domestic and foreign guidelines and technical literature, the guidelines focus on the main content that needs to be considered in the immunogenicity evaluation of low-molecular-weight heparins (LMWHs), and recommend some research methods; It aims at the development and research of imitation products, as well as provided technical reference for the post-marketing change studies that may affect the immunogenicity of such products, and promotes the development of the research and evaluation of imitation products at this stage.
3. The Center for Drug Evaluation issued the " Technical Guidelines for the Expansion of Cohort Research in the First Human Trial of Antitumor Drugs (Draft for Comment)"
In order to further standardize the expanded cohort study of the first human trial of antineoplastic drugs, CDE issued the "Technical Guidelines for the Expansion Cohort Study of the First Human Trial of Antitumor Drugs (Draft for Comment)" on August 3, and publicly solicited opinions and comments. The time limit is 30 days from the date of publication. The guidelines are intended to give tips on the risk control of the first human trial expansion cohort study of antineoplastic drugs, and to make recommendations on the overall design of the relevant research. The guidelines mainly include the introduction, the definition of the first human trial expansion cohort study and risks/challenges, application scope, cohort study purpose and considerations, trial risk control, statistical considerations, application of quantitative pharmacological methods, research protocols and regulatory considerations, etc.
4. The Center for Drug Evaluation issued the "Catalog of Reference Preparations of Chemical Generic Drugs (Forty-seventh Batch) (Draft for Comment)"
On August 3, CDE announced the 47th batch of reference preparations catalog, and the publicity period is from August 3, 2021 to August 16, 2021 (10 working days). The list of public announcements includes 15 new reference preparations, 30 supplements, and 29 varieties that have not passed the review. The reasons for the failure of the review include the lack of complete and sufficient safety and effectiveness data for the applied reference preparation, the lack of existing data to fully explain the basis for the topic of this product, the specification of the proposed reference preparation does not meet the domestic usage and dosage, the proposed reference preparation is a generic drug marketed in other countries. In order to ensure the quality of the reference preparations, it is recommended that the reference preparations should first be the original drugs approved for marketing by institutions with relatively complete regulatory systems such as the European Union, the United States, and Japan.
