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2026/07/15

Forwarding | Notice on Soliciting Comments on the "Technical Guidance Principles for Communication on Using Real-World Evidence to Support Expanded Pediatric Indications for Marketed Drugs (Draft for

To promote the development of pediatric medications in China and enhance the quality and efficiency of clinical research...
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转发 | 关于公开征求“推进新方法(NAMs)研究和应用试点计划(先锋计划)”相关工作文件意见的通知

2026/07/07

Forwarding | Notice on Soliciting Opinions on the Working Documents Related to the "Pilot Program for Advancing the Research and Application of New Approach Methods (NAMs) (Pioneer Program)"

To serve the high-quality development of the pharmaceutical industry and promote the research and application of new approach methodologies (NAMs) such as organoids and organ-on-a-chip in drug development...
转发 | 国家药监局药审中心关于发布《细胞治疗药品范围和归类技术指导原则（2026年版）》的通告（2026年第39号）

2026/07/03

Forwarding | Announcement of the Center for Drug Evaluation, National Medical Products Administration on the Publication of the "Technical Guidelines for the Scope and Classification of Cell Therapy D

In order to standardize the scope and classification of cell therapy drugs, under the deployment of the National Medical Products Administration, the Drug Evaluation Center has organized the development of the "Technical Guidelines for the Scope and Classification of Cell Therapy Drugs (2026 Edition)"...
转发 |CNAS 新版《检验机构能力认可准则》2027年1月1日起实施

2026/07/01

Forwarding | New Edition of CNAS "Criteria for the Recognition of Inspection Agency Competence" to Take Effect from January 1, 2027

To comply with the transition requirements of the new standard "Conformity Assessment - Requirements for Inspection Bodies" by the Global ACI, the China National Accreditation Service for Conformity Assessment (CNAS) has issued the CNAS-CI01:2026 "Criteria for the Accreditation of Inspection Bodies" and its transition arrangement. The new accreditation criteria will officially take effect from January 1, 2027, with a transition period set by CNAS from January 1, 2027, to March 31, 2029....
转发 | 关于中药品种保护审评相关工作调整有关事宜的通知(药审业〔2026〕250号)

2026/06/26

Forwarding | Notice on Adjustments to the Review of Traditional Chinese Medicine Variety Protection (Drug Review Industry [2026] No. 250)

According to the approval requirements of relevant departments, the Drug Evaluation Center of the National Medical Products Administration has added the brand of the National Traditional Chinese Medicine Variety Protection Evaluation Committee to undertake the evaluation work of national traditional Chinese medicine variety protection....
转发 | 中检云课GLP机构计算机化系统合规应用培训班（北京市）

2026/06/25

Forwarded | China Inspection Cloud Course: GLP Computerized System Compliance Application Training (Beijing)

Organizer China National Institute for Food and Drug Control...
药监资讯 | 国家药监局药审中心发布《中国新药注册临床试验进展年度报告（2025）》

2026/06/23

Drug Regulatory News | China National Medical Products Administration's Drug Evaluation Center Issues the "Annual Report on the Progress of New Drug Clinical Trials in China (2025)"

To showcase the current status of clinical trials for new drug registration in China, further enhance the transparency of clinical trials, and provide scientific references for new drug research and evaluation approval, the Drug Evaluation Center of the National Medical Products Administration uses clinical trial data from the Drug Clinical Trial Registration and Information Disclosure Platform...
转发 | 中检院办公室关于举办生殖与遗传毒性评价策略和案例分享培训班的通知

2026/06/15

Forward | Notice from the Office of the National Medical Products Administration on Holding a Training Course on Reproductive and Genetic Toxicity Evaluation Strategies and Case Sharing

To standardize the evaluation strategies and data interpretation of reproductive and genetic toxicity tests, and enhance the professional capabilities of practitioners in the pharmaceutical industry in the fields of reproductive toxicology and genetic toxicity...
药监资讯 | CDE发布《化学仿制药药学研究重大缺陷情形》及《化学仿制药生物等效性研究重大缺陷情形》的通告

2026/05/21

Drug Regulatory News | CDE Issues Notices on "Major Deficiencies in Pharmaceutical Research of Chemical Generic Drugs" and "Major Deficiencies in Bioequivalence Research of Chemical Generic Drugs"

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5月1日正式实施：818号令细则 | 国家卫生健康委关于印发生物医学新技术临床转化应用审批工作规范（试行）的通知

2026/05/01

Officially implemented on May 1st: Detailed Rules for Order No. 818 | Notice of the National Health Commission on the Issuance of Work Standards for the Approval of Clinical Translation and Applicatio

Notice of the National Health Commission on Issuing the Work Norms for the Approval of Clinical Translational Applications of Biomedical New Technologies (Trial)...
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