Medical Policies Weekly
1. "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Comments)"
On September 8, the Center for Drug Evaluation issued the "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Comments)" to solicit public opinions. The time limit for soliciting opinions is 1 month from the date of publication. The guidelines provide suggestions on the clinical trial design, endpoint selection, and equivalence thresholds of biosimilars for cetuximab injection. The main parts are as follows: In the "Foreword" part, it introduces the marketing situation of the original research drug and the application scope and writing purpose of the guiding principles. In the section "Clinical Research Strategies for Cetuximab Biosimilars", the general considerations for the development of biosimilars and the individual considerations for cetuximab are introduced. In the "Key points of clinical trial design of cetuximab biosimilars", the pharmacokinetic comparison study, the study design and end point selection of the clinical effectiveness comparison study are introduced in detail. And in this part, the current views of CDE on immunogenicity research and indications extrapolation are summarized.
2. "Guidelines for Random Allocation of Drug Clinical Trials (Draft for Comments)"
On September 8, the Center for Drug Evaluation issued the "Guidelines for the Random Allocation of Drugs in Clinical Trials (Draft for Comments)" to solicit public opinions. The time limit for soliciting opinions is 1 month from the date of publication. The guiding principles describe the definition of random allocation, common random allocation methods, and specific implementation and management, and provide guiding suggestions on how sponsors should correctly design clinical trial random allocation and correctly implement random allocation. The full text includes an overview, commonly used random allocation methods in clinical trials, the implementation and management of random allocation in clinical trials, other considerations, references, and appendices.
3. "Guidelines for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Comments)"
On September 8th, the Center for Drug Evaluation issued the "Guidelines for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comments)" to solicit opinions from the public. The time limit for soliciting opinions is 1 month from the date of issuance. The guiding principles set forth the technical requirements for the comprehensive analysis of the effectiveness of drug clinical research by China's regulatory agencies in terms of the definition, role, coverage, precautions and other aspects of the comprehensive analysis of effectiveness research. It is mainly used to guide the sponsor to conduct a comprehensive analysis of the effectiveness of drug clinical research, so as to show the effectiveness of the drug as comprehensively and systematically as possible. The full text mainly includes introduction, overview of individual clinical studies, overall analysis of effectiveness results, analysis of subgroups, analysis of clinical information related to recommended doses, analysis of long-term effectiveness, tolerability and discontinuation, regulatory considerations, and appendices, etc.
4. Technical Guidelines for Clinical Trials of Direct Antiviral Drugs for Chronic Hepatitis C (Draft for Comments)
On September 10, the Center for Drug Evaluation issued the "Technical Guidelines for Clinical Trials of Direct Antiviral Drugs for Chronic Hepatitis C (Draft for Comments)" to solicit public opinions. The time limit for soliciting opinions is 1 month from the date of publication. The guidelines are intended to guide the design and evaluation of new drug clinical trials for direct antiviral drugs (DAA) against chronic hepatitis C virus (HCV), covering the period from before the new drug clinical trial application to the new drug marketing application and post-marketing stage. The main content includes purpose and scope of application, disease and treatment background, early clinical trials, exploratory clinical trials, confirmatory clinical trials, other precautions and abbreviations list.
