CDE Issues Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products (Draft for Comments)

Following the publication in July and August of this year of the Technical Guidelines for Clinical Trials of Immunocell therapy Products (Draft for Comments), Guidelines for the Design of Clinical Trials of Lysovirus-type Drugs (Draft for Comments), Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derivative Cell Therapy Products, CDE has released the Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products for Gene Therapy Products (Draft for Comments).
comments, it is pointed out that the guiding principle does not include lysovirus products and CAR-T cells and other ionoid gene modification cell therapy products, but some of the relevant research of such products, such as the preparation of viral vectors, under appropriate conditions can be used for comprehensive reference.
the same time, the opinion paper on gene therapy products in the production of materials, preparation process, quality control, stability research and other aspects of the guidance and norms.
In order to standardize the pharmaceutical research of gene therapy products, unify evaluation standards, and guide the research and declaration of gene therapy products, our center, on the basis of drawing on the regulatory standards of gene therapy products at home and abroad, has formed the Guiding Principles for Pharmaceutical Research and Evaluation of Gene Therapy Products (Draft for Comments) through pre-research, document writing, expert consultation and discussion by the technical committee of the department.
public consultation through the central website () and welcomes valuable comments and suggestions from all walks of life.
if you have any further suggestions or suggestions, please fill in the request for comments feedback form and email us back.
thank you for your participation and support! Contact: Xu Longchang, Email:xulch@cde.org.cn; Wei Wei, Email: weiw@cde.org.cn; CDE Source: CDE Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to be reproduced by any media, website or individual.
all reprinted articles on this website are for the purpose of transmitting more information and clearly indicate the source and author, and media or individuals who do not wish to be reproduced may contact us and we will delete them immediately.
reproduce content at the same time does not represent the position of this site.
leave a message here.