• Application Format for Obtaining the Export NOC of Biological Samples of Clinical Trial for Testing^NEW!!                                                       
• ^{Vaccines Registered}  

• ^{Notice for Submission of Biological Application NEW!!}

• ^{Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products}

Guidance For Industry

·         Submission of Clinical Trial Application for Evaluating Safety and Efficacy

·         Requirements for permission of Drugs Approval

·         Post approval changes in biological products: Quality safety and Efficacy Documents

·         Preparation of the Quality Information for Drug Submission for Drug Approval: Biotechnological/Biological Products