Regulatory News
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NMPA CDE Announcement on Issuing the Guidance for Immunogenicity Study of Generic Drugs of Low Molecular Weight Heparin (Interim)
Pubtime：
2021-12-23
In order to standardize the research and development of low molecular weight heparin products and promote the study and evaluation of the chemical generic drugs for injection, the CDE has organized to develop the Guidance for Immunogenicity Study of Generic Drugs of Low Molecular Weight Heparin (interim) under the deployment of the NMPA, whichwas issued and implemented on August 6, 2021 upon the review and approval of the NMPA.
(August 06, 2021)