Notification - Labelling Requirements for H&OTC Products [02 Jul, 2020]

Donation of COVID-19 Convalescent Plasma [01 Jul, 2020]

Checklist for No Objection Certificate for import of unregistered/ not available medical device(s) under medical devices rules, 2017 [25 Jun, 2020]

Notification - for maximum retail price (MRP) of Remdesivir [22 Jun, 2020]

Advisory - Use of REMDESIVIR in the current COVID-19 Pandemic [19 Jun, 2020]

Notification for want of information with respect to deferred products in 79th meeting of EEC held on 14 May, 2020 [16 Jun, 2020]

Medical Product Alert - Dopacin Injection (Dopacin HCI) 200mg/5ml Batch No. DP-02 [15 Jun, 2020]

Priority Approval/Registration of Drugs Remdesivir and Tocilizumab During the COVID-19 pandemic [15 Jun, 2020]

Notification F.No.4-2/2017-DD(H&OTC):- Guidelines for export facilitation of H&OTC products [11 Jun, 2020]

Advisory on conduct of clinical trials during COVID-19 pandemic final [04 Jun, 2020]

Safety Alert of falsified and contaminated defibrotide identified in WHO regions [04 Jun, 2020]

Withdraw Notification No. F.No.4-2/2017-DD(H&OTC) dated 6 April 2020 [21 May, 2020]

Circular Priority Approval / Registration of Drugs During the COVID-19 Pandemic [07 May, 2020]

Advisory Recommendations for Interactions with Experimental COVID-19 Therapies [06 May, 2020]

Safety Alert Detection of NDMA in Ranitidine Containing Medicines [06 May, 2020]

Tender Document Supply/ Installation of Procurement of Desktop Computers, MFP Network Printers / Copiers & Mobile Tablet [04 May, 2020]

Tender Document For Biometric Machines, Customized Software & Door Locks [04 May, 2020]

Notification regarding cost recovery mechanism in respect of out-station inspections [30 Apr, 2020]

Circular Priority Approval/Registration of Drugs During the COVID-19 Pandemic [30 Apr, 2020]

Advisory Consideration for Pharmacies and Medical Stores During the COVID-19 [30 Apr, 2020]

Advisory Reminder of Risk of Serious Side Effects with Chloroquine and Hydroxychloroquine During the COVID-19 [30 Apr, 2020]

Medical Product Alert - Mariadin Injection (Ranitidine (as HCl) 50mg/2ml) [30 Apr, 2020]

Medical Product Alert - Nexalite Injection (Tranexamic Acid 250mg/5ml) [30 Apr, 2020]

Advisory on Reporting of Pharmacovigilance Data During COVID-19 Pandemic [27 Apr, 2020]

Manufacturing and Sale of Substandard Drug Paracetamol Tablet B.N0.10-M/S Ahson Drugs Company, Tando Adam Descision of 293rd Meeting of Registration Board [23 Apr, 2020]

Guidelines for Enlistment of Homeopathic Combinations [21 Apr, 2020]

Letter of cases of sanitizers Permitted in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Letter of cases of sanitizers Rejected in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Letter of cases of sanitizers Deferred in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Advisory to Protect/ Support Pharmacists on the Coronavirus (COVID-19) Frontline [16 Apr, 2020]

Fee for Issuance of GMP Certificate for Local Manufacturing and Export Purposes [16 Apr, 2020]

Safety Alert of Falsified Chloroquine Products Circulating in the WHO Region of Africa [15 Apr, 2020]

Letter of cases of sanitizers permitted in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Letter of cases of sanitizers rejected in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Letter of cases of sanitizers deferred in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Safety Alert of Falsified Medical Products, including In Vitro Diagnostics, that claim to Prevent, Detect, Treat or Cure COVID-19 [14 Apr, 2020]

[Revised Version] Guidance Document of Technical committee constituted by PEC to prepare Fast Track Acceptance Test Procedure for Locally Developed Mechanical Ventilators [13 Apr, 2020]

Letter of Permission to Prepare Hand Sanitizers [10 Apr, 2020]

Deferred Applications of Hand Sanitizers [10 Apr, 2020]

Rejected Applications of Hand Sanitizers [10 Apr, 2020]

Notification regarding Hand Sanitizer [06 Apr, 2020]

Safety Alert Serious Mental Health Side Effects with Asthma and Allergic Drugs MONTELUKAST [06 Apr, 2020]

Advisory Ensuring prescription based sale of CHLOROQUINE PHOSPHATE containing dosage forms [24 Mar, 2020]

Postponed of opening of auction of old machinery and furniture items [24 Mar, 2020]

Auction Notice - Old Machinery and Furniture Items [18 Mar, 2020]

Advisory - Postponement of Conferences, Seminars, Symposium, Workshops and Other Meeting involving Large Gathering [17 Mar, 2020]

Medical Product Alert
Availability/Sale of Unauthorized stock of potentially counterfeit Prevenar Vial Prevenar PFS Registration No. 066110 Marketed by Wyeth Pakistan Limited. [16 Mar, 2020]

Minutes of 273rd Meeting of Central Licensing Board held on 15th January, 2020 [16 Mar, 2020]

Monthly progress report of Licensing Division for the period from 01-11-2019 to 30-11-2019 [16 Mar, 2020]

Safety Alerts of falsified antimalarials in West and Central Africa displaying an outdated WHO essential drugs programme logo [13 Mar, 2020]

Complaint regarding use of RESTANE (ISOFLURANE) B.NO.NO219d16- Interim Report [03 Mar, 2020]

Visiting hours for Representatives of Pharmaceutical Firms & General Public [27 Feb, 2020]

Minutes of 293 Meeting of Registration Board [21 Feb, 2020]

Establishing Regulatory Pathway of Licensing System: A Progressive Approach
This document has been shared for initial consultation with our stakeholders. Please forward your comments on sultanghani1940@gmail.com by 26th February, 2020 [21 Feb, 2020]

Safety Alert Quality Defect in LPV Vaccine Imported from India [21 Feb, 2020]

Minutes of the 16th meeting of the Medical Device Board (MDB) held on 03-02-2020 [19 Feb, 2020]

Minutes of the 15th meeting of the Medical Device Board (MDB) held on 30-12-2019 [19 Feb, 2020]

Minutes of the 14th meeting of the Medical Device Board (MDB) held on 11-10-2019 [19 Feb, 2020]

Minutes of the 13th meeting of the Medical Device Board (MDB) held on 05-08-2019 [19 Feb, 2020]

Provisional List of Registered & Enlisted Medical Devices for Import [19 Feb, 2020]

Provisional List of Registered & Enlisted Medical Devices for Local Manufacture [19 Feb, 2020]

Advertisement Regarding Ban on Import & Local Manufacturing of Disposible Syringes [19 Feb, 2020]

Provisional List of Establishment License to Import Medical Devices [19 Feb, 2020]

Invitation to bid for Photocopies of Official Documents on need basis - Closing Date: February 20, 2020 [06 Feb, 2020]

Date wise Provisional List of Applications for Provisional Enlistment of Nutraceutical, Herbal/Unani products applied by the firms having both types of sections or import [04 Feb, 2020]

Date wise Provisional List of Application for Provisional Enlistment of Homeopathic products [04 Feb, 2020]

Date wise Provisional List of Applications for Provisional Enlistment of Herbal/Unani products [04 Feb, 2020]

Minutes of 272 meeting of the Central Licensing Board (CLB) [30 Jan, 2020]

Activities in Drug Licensing Division for the month of October, 2019 [30 Jan, 2020]

Draft Amendment in Rule 27 of the Drugs (L,R&A) Rules 1976 for extension in time for renewal of Drug Registration
["Stakeholders may submit their comments to Division of Legal Affairs within fourteen days (by 03-Feb-2020)."] [21 Jan, 2020]

Notification of Members of the Appellate Board [16 Jan, 2020]

Request for Expression of Interest (EOI) for Hiring Individual Consultant [15 Jan, 2020]

S.R.O. 1572(I)/2019 Notification of Drugs Control and Traditional Medicines Division (NIH) appellate laboratory for certain medical devices [13 Jan, 2020]

S.R.O. 1571(I)/2019 Notification of CDL for testing the quality, safety and performance of certain medical devices [13 Jan, 2020]

Guidelines for Manufacturer/Importer of "Food Supplement" or "Dietary Supplement" or "Health supplement" or "Nutraceuticals" as to what is meant by "Alternative Medicine and Health Products Dosage Forms" [13 Jan, 2020]

Costing and Pricing S.R.O 09(I)/2020 [07 Jan, 2020]

Draft Amendments in the Drugs (L,R&A) Rules, 1976 for Test and Analysis of Drugs on Contract
["Stakeholders may submit their comments to Division of Licensing within fifteen days (i.e: 18-Jan-2020)."] [03 Jan, 2020]

Costing and Pricing S.R.O 913(1)/2017 [03 Jan, 2020]

Tender documents supply/ installation of hardware (server, scanners & barcode printers) [27th Dec, 2019]

S.R.O. 1460(I)/2019 Amendments in the Drugs (Licensing, Registration and Advertising) Rules, 1976 [29th Nov, 2019]

Minutes of 292 Meeting of Registration Board - Held on 1st-2nd October, 2019 [21th Nov, 2019]

List of valid Drug Manufacturing Units operating in Pakistan [15th Nov, 2019]

Guidelines for the Conduct of Clinical Trial - 1st Edition [14th Nov, 2019]

List of renewal application of year 2018 approved by Registration Board [13th Nov, 2019]

List of renewal application of year 2018 deferred by Registration Board for the rectification of shortcomings [13th Nov, 2019]

Invitation to Bid (For Photocopies of Documents/Old Record) [11th Nov, 2019]

Alert Of Falsified Quinine Bisulphate: Circulating In Uganda And Quinine Sulphate Circulating In Central African Republic And Chad [8th Nov, 2019]

Draft Guideline for PRIORITY REVIEW AND ACCELERATED APPROVAL OF REGISTRATION / MARKET AUTHORIZATION (1st Edition)
["Stakeholders may submit their comments to Division of PE&R within fifteen days (till date: 15-Nov-2019) on the following email address: addl-dir.pe.reg@dra.gov.pk"] [07th Nov, 2019]

Draft Guideline for PRIORITY REVIEW AND ACCELERATED APPROVAL OF REGISTRATION / MARKET AUTHORIZATION (1st Edition)
["Stakeholders may submit their comments to Division of PE&R within fifteen days (till date: 15-Nov-2019) on the following email address: addl-dir.pe.reg@dra.gov.pk"] [29th Oct, 2019]

List of Federal Inspector of Drugs [04th Oct,2019]

CTD- Pre Submission Screening Checklist [29th Sep,2019]

Training Manual of IRIMS [1st Aug,2019]

Training of Drug-Integrated Regulatory Information Management System (D-IRIMS) for Pharmaceutical Industry [11th July,2019]