The Center for Drug Evaluation (CDE) has released a series of Technical Guidelines aimed at standardizing pharmaceutical research, development, production, and registration processes in China. The guidelines cover a range of areas including human-derived stem cell products, drugs for the treatment of chronic hepatitis B virus infection, and active immunotherapy products for tumors.
Regulating Human Stem Cell Products
The “Guiding Principles for Pharmaceutical Research and Evaluation Technology of Human Stem Cell Products” provide a framework to regulate and guide the research and development of human stem cell products. These guidelines encompass considerations for pharmaceutical research, production materials, processes, quality standards, stability research, packaging, and sealed container systems, ensuring a comprehensive approach to the development of stem cell therapies.
Chronic Hepatitis B Virus Infection Treatment Drugs
The “Technical Guidelines for Clinical Trials of Drugs for the Treatment of Chronic Hepatitis B Virus Infection” offer general technical guidance for the design, implementation, and evaluation of clinical trials for new drugs targeting chronic hepatitis B virus. These guidelines are crucial for clinical pharmacology research, exploratory clinical trials, confirmatory clinical trials, and other related areas, providing a structured path for the development of effective treatments.
Active Immunotherapy Products for Tumors
The “Technical Guidelines for Clinical Trials of Active Immunotherapy Products for Tumors” provide technical guidance for the clinical trial design of tumor active immunotherapy products. These guidelines include research and design recommendations for early exploratory clinical trials and confirmatory clinical trials, aiming to enhance the efficacy and safety of immunotherapy approaches in oncology.-Fineline Info & Tech
