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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

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International Briefing Workshop on WHO Pre-qualification Programme (PQP)for Indian Manufacturers of In Vitro Diagnostics on 09th June, 2015 at New Delhi

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Notifications !!  

 

 Revised conditions 

 for purchase of :

 

1. Sera Panels

 

2. National Reference Standards

 

 

 

Revised specification/criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kitsnew

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016new

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2003new

 

Turnaround time for testing new

 

 

 

Guidance Document for Industry : submission of stability data and related documents for review & expert opinion for granting post approval changes in shelf life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodiesnew

 

 

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in Indianew

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