The National Health Commission (NHC) has released the “Technical Guidelines for Comprehensive Clinical Evaluation of Cardiovascular Drugs,” “Technical Guidelines for Comprehensive Clinical Evaluation of Antineoplastic Drugs,” and “Technical Guidelines for Comprehensive Clinical Evaluation of Children’s Drugs” (all 2022 trial versions), effective as of July 1, 2022.
Background
The NHC released the 2021 version of the “Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs” in July of last year. These guidelines require local health commissions, medical equipment centers, medical development centers, the National Center for Cardiovascular Diseases, the National Cancer Center, and the Children’s National Medical Center to conduct comprehensive clinical evaluations in terms of safety, efficacy, cost-effectiveness, innovation, suitability, and accessibility.
Evaluation Design and Methods
The new guidelines provide detailed instructions on evaluation design, evaluation methods, and research design, including reviews, real-world studies, and modeling studies. These guidelines aim to ensure a comprehensive and standardized approach to the clinical evaluation of drugs, enhancing the quality and reliability of drug assessments in China.-Fineline Info & Tech
