NEWS
News Updates
Information Center
2021-08-09
Notice on Public Solicitation of Comments on the “Technical Guidance Principles for Expanded Cohort Studies in First-in-Human Trials of Antitumor Drugs (Draft for Comments)”
2022-11-25
The Drug Review Center has organized the development of the “General Guiding Principles for Involving Patients in Drug Research and Development (Trial)” (see attachment). In accordance with the requirements of the “Notice from the Comprehensive Division of the National Medical Products Administration on Issuing the Procedures for Publishing Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, this document is hereby released and shall take effect as of the date of its publication.
2022-11-09
To further standardize and guide the benefit-risk assessment in clinical research and evaluation of drugs, and to provide referenceable technical guidelines, our center has drafted the “Technical Guidance Principles for Benefit-Risk Assessment of New Drugs.” After internal discussions within the center, a draft for public comments has been prepared.
2022-11-02
To guide marketing authorization holders of pharmaceutical products in conducting standardized production and quality management of cell therapy products and to ensure product quality, the Inspection Center has organized research and drafted the “Guidelines for Production and Quality Management of Cell Therapy Products (Trial).” These guidelines are now being released and should be followed accordingly.
2022-10-28
The clinical trial protocol is the core document used by the Drug Review Center to evaluate clinical trial applications and engage in communication and exchange based on the clinical trial protocol itself. The design of the clinical trial protocol directly affects the quality of the drug’s clinical trials and is also a critical component for ensuring the safety of subjects and obtaining high-quality data. To enhance the quality of clinical trial protocols prepared by applicants, standardize communication and exchanges related to these protocols and various registration applications, improve the quality of protocol reviews, and strengthen technical guidance provided to applicants, our Center has drafted the “Guidelines for the Review of Drug Clinical Trial Protocols (Draft for Comments).”
2022-10-28
Clinical safety evaluation of new drugs is an essential foundation for assessing the benefits and risks of these drugs. To further provide scientific guidance on the safety evaluation of new drugs, the Center has drafted the “Technical Guidance Principles for Clinical Safety Evaluation of New Drugs.” After internal discussions within the Center, a draft for public comments has been prepared.
2022-10-24
To promote and guide the research and development of pediatric drugs, the Center for Drug Evaluation of the National Medical Products Administration has organized the drafting of the “Guiding Principles for Quantitative Methodology on Extrapolating Adult Drug Data to Pediatric Populations (Draft for Comments).” We are now soliciting public comments.
2022-10-24
To address the special concerns that arise in the clinical development of antibody-drug conjugates for cancer treatment and to guide enterprises in conducting more scientifically sound clinical research and development, the Center for Drug Evaluation has prepared the “Technical Guidance Principles for Clinical Development of Antibody-Drug Conjugates for Cancer Treatment.” A draft for public comments has been formulated and is now available for reference by those involved in drug research and development.
Leave a message for inquiry
Follow us
Address: Room 3008, Building I, Yingkun Century, No. 6 Courtyard, East Road of the Automobile Museum, Fengtai District, Beijing
Phone: +86 10 86229816 Fax: 010-83739030
Email: bd-oyhz@healtech.com.cn (Business Cooperation)
ouyahuizhi-hr@healtech.com.cn (Resume Submission)
Follow the official account
WeChat Official Account
Friendship Links:Beijing Aotekang Pharmaceutical Technology Development Co., Ltd. Suzhou Suhao Biomaterials Technology Co., Ltd. Beijing Dikang Pharmaceutical Investment Management Co., Ltd. Center for Drug Evaluation, National Medical Products Administration National Medical Products Administration
Copyright © Eurasia Huizhi (Beijing) Medical Research Co., Ltd.