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Announcement by NMPA: Drug GLP Certification

时间:2022-07-19 11:25:14 文章来源:苏州慧疗生物

Introduction: Recently, the National Medical Products Administration (NMPA) issued an announcement regarding the certification of Good Laboratory Practice (GLP) for drug non-clinical studies (No. 5, 2022, Announcement No. 27). Details are as follows. 

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In accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Drug Non-Clinical Studies" (Drug GLP), and the "Administrative Measures for the Certification of Good Laboratory Practice for Drug Non-Clinical Studies," the National Medical Products Administration organized experts to conduct inspections of 13 institutions, including Hunan Primac Drug Research Center Co., Ltd. Upon review, the single-dose and repeated-dose toxicity tests (rodents) and other test items of these 13 institutions were found to comply with Drug GLP requirements (see attachment).


Hereby announced.

Attachment: Drug GLP Certification Directory

National Medical Products Administration

March 24, 2022

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