Module 9 2024

03/09/2024

Guidelines relevant for nonclinical evaluation (cont.)

2: Guidelines from national regulatory agencies (NR): examples

⚫ Notice on the issue of technical guidelines for preclinical research on preventive vaccines; SFDA (April 2010) ⚫ Guideline for Non-clinical Studies of Vaccines for Preventing Infectious Diseases (PFSB/ELD 0527-1); Japan MHLW 2010

The Organisation for Professionals in Regulatory Affairs

81

Specific Considerations for Vaccines Clinical

The Organisation for Professionals in Regulatory Affairs

82

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