Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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NCLB implements Lot release and Lab testing of Biological Drugs as per Schedule I of DRAP Act, 2012 (Act No. XXI of 2012)

and is part of DRAP Authority under Section 3 of this Act.

2021 is 21st year of service of NCLB


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Vaccine Standardization:

Standardization of Biotherapeutic Products:

List of Pre qualified vaccine:

Priority setting for WHO vaccine prequalification:

Vaccine regulation:

Medicines regulatory support:

Assessing national medicines regulatory systems:

Regulatory information and practical manuals:

WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems:

Vaccine PQ:

Vaccine manufacturers' corner:

WHOPIRs for manufacturing sites inspected by WHO-PQT:

WHO-National Control Laboratory Network for Biologicals (WHO-NNB):

Vaccine Prequalification Dossier:

WHO prequalification: information and guidance documents for vaccine manufacturers:

Revised procedure for expedited review of imported prequalified vaccines for use in national immunization programmes:

Environmental monitoring of clean rooms in vaccine manufacturing facilities:

Good Manufacturing Practices; TRS 999 Annex 2 Replacement of Annex 1 of WHO Technical Report Series, No. 822:

Pharmaceutical Production main principles:

WHO Good manufacturing practices list (GMP):

WHO guideline for quality Risk Management: Annex 2, WHO Technical Report Series 981, 2013



List of Products presently under going Lot Release Performance of NCLB Lot Release system from 2007 onwards  

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Last modified: 13-Jul-2021