Regulatory Requirements for Investigational Drugs - กระทรวงสาธารณสุข

Thailand
Food &
Drug
Administration
PILOTING OF THE IND-LIKE PROCESS :
ตัวอย่าง การพัฒนา Pandemic Live Attenuated Influenza vaccine
(PLAIV) (H1N1) By Local manufacturer
• Pre IND Meeting between NRA and sponsor/manufacturer
– Product description/product characteristic
– Preclinical data
• IND Meeting Prior to Phase I-II :
– Pre-clinic and Clinical lot production
– Clinical Trial Protocol Development (objectives, design,
number of subject, schedule)
• Dossier for registration MA