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Drug Regulatory Authority of Pakistan

Drug Regulatory Authority of Pakistan

Ministry of National Health Services, Regulations & Coordination

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Home > News & Updates > Regulatory Updates > General

General

Guideline for Lot Release of Human Vaccines, Blood Products (Plasma-Derived Medicinal Products), and Anti-Sera

Abdul Qadir General November 27, 2025November 27, 2025
document-8Download

Mandatory submission of lot release applications for biological products through the online lot release portal

Ijaz Mustafa General September 23, 2025September 23, 2025
Lot-releaseDownload

Submission of Required Details for Implementation of 2-D Barcode & Serialization by 1st September 2025

Yasir Mahmood General August 29, 2025August 29, 2025

Drug Regulatory Authority of Pakistan (DRAP) is in process of implementing 2-D Barcode along with serialization for pharmaceutical products. In this regard, the pharmaceutical industry is hereby directed to provide the required details in the attached form not later than 1st September, 2025.

Click here to open form

Health emergencies preparedness and risk management plan

Yasir Mahmood General July 21, 2025July 21, 2025
DRAP_Health_Emergency_Preparedness_Plan-1-1Download

Guidance document for requirement of clinical trials or bio-similarity studies for registration of locally manufactured biological drugs for humans

Ijaz Mustafa General July 21, 2025July 21, 2025
GUIDANCE-DOCUMENT-FOR-REQ.-OF-CLINICAL-TRIALS-OF-BIOLOGICAL-PRODUCTSDownload

Pakistan Clinical Research Landscape Report 2025

Muhammad Ayub Naveed Clinical Trials, General July 18, 2025July 24, 2025
10th-Feb-Pakistan-Clinical-Trial-Landscapre-_12-feb-1Download

FIFO list of Class A,B,C,D Medical Devices for Import

Ijaz Mustafa General, Medical Devices, Uncategorized June 24, 2025July 16, 2025
FIFO-list-of-Class-A-Medical-Device-for-ImportDownload
FIFO-list-of-Class-B-Medical-Device-for-ImportDownload
FIFO-list-of-Class-C-Medical-Device-for-ImportDownload
FIFO-list-of-Class-D-Medical-Device-for-ImportDownload

Guidelines for conduct and reporting of good clinical practice inspections

Ijaz Mustafa Clinical Trials, General June 23, 2025June 23, 2025
Guidelines-for-Conduct-Reporting-of-GCP-Inspection-3rd-Edition-16-05-2025Download

Guidance on Emergency Use Authorization

Ijaz Mustafa General June 17, 2025June 17, 2025
Guidence-on-emergency-authorizationDownload

Date wise provisional list of applications for provisional enlistment of  herbal,Homeo,Neutraceutical products  applied by nutraceutical firms

Ijaz Mustafa Alternative Medicines, General June 13, 2025June 13, 2025

Herbal

FIFO-2025-HERBAL-1Download

Homeo

FIFO-2025-HOMEO-1Download

Neutraceutical

FIFO-2025-NUTRA-1Download
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Drug Regulatory Authority of Pakistan

  • Islamabad | Karachi | Lahore | Peshawar | Quetta
  • Phone: 0800-03727 (Mon to Fri 08:30AM to 04:30PM)
  • Website: www.dra.gov.pk
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