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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.
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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