Guiding Principles for Research on Immunogenicity of Low Molecular Weight Heparin Generic Drugs Released

On August 6, CDE's official website released the "Guiding Principles for Research on the Immunogenicity of Low Molecular Weight Heparin Generic Drugs (Trial)"

The original text is as follows:

Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Guiding Principles for Research on the Immunogenicity of Low Molecular Weight Heparin Generic Drugs (Trial)"

Release date: 20210806

In order to standardize the research and development of low-molecular-weight heparin products, and to promote the research and evaluation of chemical generic drug injections, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation organized the formulation of the "Immunogenicity Study of Low-molecular-weight Heparin Generic Drugs" Guiding Principles (for Trial Implementation)" (see attachment)

Attachment 1: Guiding Principles for Immunogenicity Research of Low Molecular Weight Heparin Generic Drugs (Trial)