Lates Drug Registration Technical Lectures

Author: Li Jun
Publisher:
Publish Date: 2005-06-01
Features: Drug registration is a highly policy-based and technical task. After the State Drug Administration released the "Measures for Drug Registration Management" (for trial implementation) in October 2002, it revised and released the "Good Laboratory Practice" (GLP) for non-clinical drug research quality management and the "Good Clinical Practice" (GCP) for clinical drug trials in August 2003. Following the implementation of the "Administrative Licensing Law," it further revised and released the "Measures for Drug Registration Management" in April 2005. To enable pharmaceutical enterprises and non-clinical research and clinical trial units to accurately implement relevant regulations on drug registration, this book explains the technical requirements of drug registration in an overview and Q&A format, based on the newly revised relevant regulations. It is divided into five parts—General Principles, Drug Registration Applications, Non-clinical Drug Research, Clinical Drug Trials, and Drug Registration Approval—comprising 18 chapters. The content of this book is closely aligned with the country's newly revised registration requirements and closely meets the practical needs of drug registration work. It is characterized by its easy-to-understand language and concise content. It serves as a reference for technical personnel in pharmaceutical enterprises, research institutions, and medical institutions, and is also suitable for drug regulatory personnel, faculty and students of higher medical colleges, and the general public. It can be used as a training textbook for drug registration work. Drug registration is a highly policy-based and technical task. After the State Drug Administration released the "Measures for Drug Registration Management" (for trial implementation) in October 2002, it revised and released the "Good Laboratory Practice" (GLP) for non-clinical drug research quality management and the "Good Clinical Practice" (GCP) for clinical drug trials in August 2003. Following the implementation of the "Administrative Licensing Law," it further revised and released the "Measures for Drug Registration Management" in April 2005. To enable pharmaceutical enterprises and non-clinical research and clinical trial units to accurately implement relevant regulations on drug registration, this book explains the technical requirements of drug registration in an overview and Q&A format, based on the newly revised relevant regulations. It is divided into five parts—General Principles, Drug Registration Applications, Non-clinical Drug Research, Clinical Drug Trials, and Drug Registration Approval—comprising 18 chapters. The content of this book is closely aligned with the country's newly revised registration requirements and closely meets the practical needs of drug registration work. It is characterized by its easy-to-understand language and concise content. It serves as a reference for technical personnel in pharmaceutical enterprises, research institutions, and medical institutions, and is also suitable for drug regulatory personnel, faculty and students of higher medical colleges, and the general public. It can be used as a training textbook for drug registration work.