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This site contains the documents, explanations, and relevant portions of minutes of meetings of Drug Registration Board for the registration, import and local manufacture of Biological Drugs as defined in Schedule I of the DRAP Act, 2012

For DRAP main site please log on to: http://DRA.GOV.PK

For details about Lot Release, sampling procedures and current fee please log on this link of

National Control Laboratory for Biologicals -
(http://www.nclbmoh.gov.pk)

DBER   ECBD Members
ABOUT DRAP
Drug Regulatory Authority of Pakistan (DRAP) was established under DRAP Act, 2012 (Act No. XXI of 2012). DRAP is to provide effective coordination and enforcement of the Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of therapeutic goods. DRAP is an autonomous body under the administrative control of the Federal Government with its headquarters at Islamabad.DRAP is an Authority that is composed of a Chief Executive Officer and thirteen Directors, and a Policy Board that oversees the working of DRAP and gives Policy Guidelines. Presently DRAP is attached to the Ministry of National Regulations and Services. Ministry of National Regulations and Services has been renamed in May 2013 as:
"Ministry of National Health Services, Regulations and Coordination"
  BIOLOGICAL DRUGS
Biologicals drugs have been recognised as separate entity and have been given a separate Division of Biological Evaluation and Research (DBER).

Information about DRAP
Policy Board of DRAP
Functions 
Meetings

Authority of DRAP Defined
Composition
Powers & Functions 
Meetings

Chief Executive Officer (CEO DRAP)

Guidance for Industry


    LAWS AND REGULATIONS
1. The DRAP Act, 2012
2. The Drugs Act, 1976
3. Drugs (Lic., Reg., and Advertising) Rules, 1976
4. Drugs Specification Rules, 1978
5. Drugs (Appellate Board) Rules, 1978
6. Drugs Import and Export Rules, 1978
 

 

 



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Last modified: 15-Mar-2015 11:06