Since joining the International Council for Harmonization (ICH) as a full regulatory member in June 2017, China has made great efforts to improve various laws, regulations, and guidelines.
The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) usually issues multiple guidelines before the weekends and each holiday. We call these a big “holiday tribute” for patients, policy-makers, and the pharmaceutical industry. Since January 1st, 2021, 23 guidelines have been issued by CDE, nine of which came before the Spring Festival, including:
Guidelines for Clinical Trials of Antimicrobial Drugs for Complex Abdominal Infections (No. 10 of 2021) ;
Standardizes the clinical research and evaluation of antibacterial drugs for complicated intra-abdominal infections. Gives recommendations under the framework of Guidelines for Clinical Trials of Antibiotics (Apr.3, 2015) .
Guidelines for the Research on Generic Drugs of Fulvestrant Injection (try-out) (No. 11 of 2021);
Alleviates the shortage of clinical supply of fulvestrant injection and accelerates the marketing of its generic drugs. Provides guidance on the technical requirements for pharmaceutical research and non-clinical research during the development of generic drugs, and clarifies the eligibility criteria for a waiver of bioequivalence studies in humans .
Guidelines for Clinical Trials of Intravenous Human Immunoglobulin for the Treatment of Primary Immune Thrombocytopenia (try-out) (No. 12 of 2021);
Guides and standardizes the clinical trials of immunoglobulin for intravenous administration (IVIg) for the treatment of primary immune thrombocytopenia (ITP). It mainly describes the key content in pre-marketing and post-marketing clinical trials of IVIg for ITP patients; outlines the required trials for post-approval changes (e.g., chemistry structure and activity). In the end, it gives advice on the risk management plan .
Guidelines for the Design of Clinical Trials of Oncolytic Viruses (try-out) (No. 13 of 2021);
Guides and standardize the clinical trials of oncolytic viruses for the treatment of malignant tumors. It describes key points in the design of exploratory and confirmatory clinical trials. What’s more, it gives advice on the risk management plan .
Guidelines for Clinical Trials of Immune Cell Therapy Products (try-out) (No. 14 of 2021) ;
Specifies the clinical recommendations for immune cell therapy products in clinical trials under the framework of Guidelines for Research and Evaluation of Cell Therapy Products (December 22nd, 2017) . Provides guidance on the clinical design for exploratory and confirmatory trials of Immune Cell Therapy Products. What’s more, it outlines the suggestions on long-term follow-up and post-marketing study or surveillance.
Guidelines for the Study of Post-approval Pharmacy Changes to Chemical Drugs (try-out) (No. 15 of 2021);
Applicable to studies on changes of Chemical raw materials and chemical preparations to an approved chemical drug .
Guidelines for Post-approval Clinical Changes to Chemical Drugs and Biological Products (No. 16 of 2021);
Clarifies the clinical changes of an approved drug in China and applies to chemicals, preventive biological products, and therapeutic biological products .
- Guidelines for Acceptance and Review of Changes to Chemical Drugs (try-out) (No. 17 of 2021);
Applies to the supplementary application items reviewed by the CDE (including the period of drug clinical trials) .
Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Draft, opening for Comments).
Provides recommendations for the non-clinical development of gene therapy products. It advises that non-clinical studies should follow the 3R principle of “Replacement, Reduction, Refinement, to avoid unnecessary use of animals and other resources .
For more information: http://www.cde.org.cn/news.do?method=news_index
Xiaojing Li, MMed
Senior Medical Manager, CSPC Pharma Ltd, China
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