Medical Policies Weekly
1.NMPA issued the 49th batch of generic drug reference listed drugs catalog
After review and determination by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of NMPA, NMPA issued a catalogue of generic reference listed drugs (forty-ninth batch) on December 8.
2. CDE issued a number of technical guidelines and drafts for comments
Recently, CDE has issued a number of technical guidelines and drafts for comments:
"Technical Guidelines for the Application of Biomarkers in the Clinical Research and Development of Anti-tumor Drugs" is applicable to the application of biomarkers in the clinical research and development of anti-tumor chemicals and therapeutic biological products, and aims to systematically elaborate the definition, classification and development of biomarkers , focusing on the application of biomarkers in the study of the effectiveness and safety of anti-tumor drugs, and clarifying the scientific issues that need to be paid attention to in clinical research and development based on biomarkers.
" Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-New Coronavirus Chemical Drugs (Trial)", the main content includes introduction, antiviral mechanism research, in vitro antiviral trial, in vivo pharmacodynamic trial, and other related considerations, suitable for chemical drugs intended to treat new coronavirus infections through direct antiviral effects.
“Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-New Coronavirus Pneumonia Inflammatory Drugs (Trial)”. The main contents include introduction, overall considerations, in vitro pharmacodynamics, in vivo pharmacodynamics, and conclusions, which is suitable for chemical drugs and biological products with anti-inflammatory effects, clear mechanisms, and intended to treat the inflammation of new coronavirus pneumonia.
"New Coronavirus Neutralizing Antibody Drugs Non-clinical Research Technical Guidelines (Trial)", the main content includes introduction, basic considerations, test substance requirements, pharmacological tests, pharmacokinetic tests, and toxicological tests, which are used to guide non-clinical research on the neutralizing antibody against COVID-19 under emergency conditions.
"Technical Guidelines for Clinical Trials of Weight Control Drugs" are mainly applicable to innovative weight control drugs developed in China, and only target simple obesity (primary obesity), focusing on suggestions on the considerations of confirmatory clinical trial design. The main content includes an overview, overweight and obesity criteria and indications for drug treatment, clinical trial design points, safety, special populations, and references.
valuation of Intravenous Anesthetics (Draft for Comment)", which elaborates the general idea of intravenous anesthetics clinical research and specific requirements for confirmatory clinical trials, including population, selection of surgical procedures, selection of main efficacy indicators, etc.
"Advanced Prostate Cancer Clinical Trial Endpoint Technical Guidelines (draft for comments)", advanced prostate cancer has unique disease characteristics, and the efficacy evaluation endpoint is different from other solid tumors. This guideline aims to systematically elaborate prostate cancer-specific endpoints. For example, the definition and influencing factors of indicators such as, rPFS、MFS、BOR, PSA90, and how to select and evaluate them in different clinical research and development stages.
