Types of Registration Application for Pharmaceuticals in Japan: In a nutshell
Pharmaceuticals and Medial Device Agency is the is the regulating Authority for Pharmaceuticals in Japan. This Agency came to force on 1/04/2014. The various registration Application are as follows: 1.Clinical Trial Notification for New drug development (IND). 2.New Drug Approval Application. 3.Generic Drug Approval Application. 4.Orphan Drug Application. 5.Priority review. 1. Clinical Trial Notification for New drug development (IND): Ø This Application is important if the company intends to conduct clinical trial for a drug and to collect data for applying for manufacturing/marketing. Ø The Clinical trial should be conducted as per Good Clinical Practice. Ø If the Clinical trial is conducted for drugs with new APIs, Drugs with new route of administration, or if the drug is a new combination product, the clinical trial protocol has to be submitted. Ø The review of application till takes 30 days after start of clinical trial. Ø The ...