S.R.O 421(I)/2021 (Draft Amendments in Rule 20A and Schedule-II of the Drugs (Licensing, Registering and Advertising) Rules, 1976 ) [07 Jun, 2021]

Notification Regarding Amendments in Form-2 of the Medical Devices Rules,2017 [07 Jun, 2021]

National Biosafety Guidelines for Research, Development & Production of Human Stem Cell  [03 Jun, 2021]

Disclaimer: This is the first version of National Biosafety Guidelines for Research, Development & Production of Human Stem Cells

Collaboration among OIC Members Countries for Promotion of Research Culture in Medicines and Vaccines through Strengthening and Upgrading the Clinical Trials [03 Jun, 2021]

RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS GUIDELINES (DRAFT) Due date of comments: 17-06-2021, send comments/suggestions/views to Additional Director (QA&LT), 3rd floor, TF Complex, G-9/4, Mauve Area, Islamabad OR via E-mail at addl-dir.qa@dra.gov.pk [27 May, 2021]

HOLDING OF KHULI E-KACHEHRI [24 May, 2021]

Online Fee Challan System - Revised User Guide dated 19-05-2021 [19 May, 2021]

Notification F7-11 2012(Revised Fee) [07 May, 2021]

SRO 526(I)2021 [04 May, 2021]

Deficiency letter of all deferred products in 85th meeting of EEC held on 04-02-2021 [27 APR, 2021]

Deficiency letter of all deferred products in 84th meeting of EEC held on 09-12-2020 [27 APR, 2021]

Public Notice [27 APR, 2021]

Deployment of Pakistan Integrated Regulatory Information Management System(PIRIMS) at DRAP [26 APR, 2021]

Holding Of Khuli E-Kachehri [23 APR, 2021]

Procedure to administer COVID-19 vaccine by Private Healthcare Facilities [02 APR, 2021]

User Guide for Online Fee Challan System [29 MAR, 2021]

Advertisement for the post of CEO [22 MAR, 2021]

Rescinding of SRO 133(I) 2021  [22 MAR, 2021]

Holding of E-Kachehri [19 MAR, 2021]

Addendum: COVID-19 Vaccination Updated Sinopharm Vaccine Guidelines [12 MAR, 2021]

Model batch certificate of a pharmaceutical product WHO [07 MAR, 2021]

Certificate of Analysis [Sample] - Quality Assurance Division [07 MAR, 2021]

Deficiency Letter of All Deferred Products in 83rd Meeting of EEC Held on 26-10-2020 [26 FEB, 2021]

Deficiency Letter of All Deferred Products in 82nd Meeting of EEC Held on 24-09-2020 [26 FEB, 2021]

Tender Document / Terms & Conditions For Hiring Of Janitorial Services [23 FEB, 2021]

Tender Documents for Provision of Internet Bandwidth Dedicated CIR  [23 FEB, 2021]

[PRESS NOTE] - Medical Devices & Medical Cosmetics Division [20 FEB, 2021]

Holding of E-Kachehri [19 FEB, 2021]

Online Application for Import/Export of Medicine for Personal Use Has Been Launched for Public (Click Here To Access) [17 FEB, 2021]

Guidelines to Establish Adult Vaccination Center (AVC) in Private Healthcare Facilities. [16 FEB, 2021]

Guide for National Immunization Management System(NIMS) [11 FEB, 2021]

FAQ's Regarding import of COVID-19 Vaccine in Pakistan [11 FEB, 2021]

Application for NOC under SRO 135(I)/2021 dated 2nd FEB 2021 [11 FEB, 2021]

Application for NOC under SRO 134(I)/2021 dated 2nd FEB 2021 [11 FEB, 2021]

ADVISORY: DISCLOSURE OF EXCIPIENTS ON LABELING AND LEAFLETS FOR INFORMATION OF PATIENTS AND PRESCRIBERS [09 FEB, 2021]

SRO 133(I) / 2021 [09 FEB, 2021]

SRO 134(I) / 2021 [09 FEB, 2021]

SRO 135(I) / 2021 [09 FEB, 2021]

Minutes of 299th Meeting of Registration Board [03 FEB, 2021]

Minutes of 298th meeting of Registration Board [03 FEB, 2021]

GUIDELINES ON RESPONSIBLE USE OF ANTIMICROBIALS IN HUMAN HEALTH [29 JAN, 2021]

CIRCULAR: Establishment of Facilitation Desk for Submission of Application on Form 5-F [28 JAN, 2021]

Frequently asked questions about Form 5F (Common Technical Document) [28 JAN, 2021]

Common Technical Document (CTD) for Registration of Human Drugs (FORM 5-F) [28 JAN, 2021]

CIRCULAR: SUBMISSION OF FORM 5-F WITH 03 MONTHS PRODUCT DEVELOPMENT AND STABILITY STUDY DATA.

Intimation of Drug Regulatory Authority’s decision on Stem Cells

Emergency Use Authorization for Covid-19 Vaccines

HOLDING OF KHULI E-KACHEHRI

Press Note: Two COVID-19 vaccines granted Emergency Use Authorization (EUA) in Pakistan

E-Kachehri

Draft National Biosafety Guidelines for Research, Development, and Production of Human Stem Cells (14/12/2020)

Note: “Comments/input within 15 days is requested from relevant stakeholders & the general public etc.(Pharmacy Services Division)”

Reduction in the Price of Remdesivir injection ( NOTIFICATION (S.R.O 1305(I)/2020) )

Draft Guidelines on Responsible Use of Antimicrobials

Note: “Comments/input within 15 days is requested from relevant stakeholders in use of antimicrobials including healthcare delivery organizations, healthcare professionals and healthcare professional councils i.e. Pakistan Medical Commission Council, Pakistan Pharmacy Council and Nursing Council, Pharma Bureau, Pakistan Pharmaceutical Manufacturers Association (PPMA) etc”

Deficiency letter of all deferred products in 81st meeting of EEC held on 25-8-2020

Notice for Importers / Pharmaceutical Companies for creation of user accounts on PIRIMS

All the importers /Pharmaceuticals Companies are advised to create login registrations at PIRIMS up to 30th November 2020, Your provisional username and passwords will be issued after the registration process in PIRIMS Software.

User Manual of PIRIMS for pharmaceutical companies

DEADLINE FOR THE CREATION OF PHARMACEUTICAL COMPANIES USER ACCOUNTS ON PIRIMS SOFTWARE

Message of CEO DRAP on World Antimicrobial Awareness Week.

Minutes of 296th Meeting of Registration Board

PREVENTATIVE MEASURES FOR COVID-19 IN DRAP

Circular

List of Approved BA/BE Studies Center under the Bio-Study Rules 2017

List of Approved BA/BE Studies under the Bio-Study Rules 2017

List of Approved Bio-Analytical Lab under the Bio-Study Rules 2017

List of Approved Clinical Trials/Studies Under the Bio-Study Rules 2017

List of Approved Contract Research Organizations (CROs) Under the Bio-Study Rules 2017

List of Approved Clinical Trial Sites Under the Bio-Study Rules 2017

Launch of Med Safety Mobile App

REACHING OUT TO PUBLIC THROUGH HOLDING OF E-KACHEHRI

SRO.1100(I)/2020

SRO.1096(I)/2020

TENDER DOCUMENTS FOR SUPPLY OF Mobile Tablets

TENDER DOCUMENTS FOR SUPPLY/ INSTALLATION OF PHOTOCOPIERS

GUIDANCE DOCUMENT FOR SUBMISSION OF APPLICATION ON FORM 5-F (CTD) FOR REGISTRATION OF PHARMACEUTICAL DRUG PRODUCTS FOR HUMAN USE.  [12 OCT, 2020]

SRO-967(I)2020  [05 OCT, 2020]

DRAFT GUIDE LINES FOR COMPLAINT HANDLING  [06 OCT, 2020]

FAST TRACK REGISTRATION OF FLUDROCORTISONE  [15 Sep, 2020]

Online Hands On Training of Pakistan Integrated Regulatory Information Management System(PIRIMS)  [10 Sep, 2020]

Reaching Out to public through holding of E kachehri [09 Sep, 2020]

Registration of Potassium Iodide tablet as registered drug [03 Sep, 2020]

Tender for Stationery Item 2020-21, DRAP [02 Sep, 2020]

Notification for Designated official under right of access to information Act,2017(XXXIV) [25 Aug, 2020]

Deficiency letter of all deferred products in 80th meeting of EEC held on 26-6-2020- Part-2.pdf [24 Aug, 2020]

Deficiency letter of all deferred products in 80th meeting of EEC held on 26-6-2020 [19 Aug, 2020]

National Essential Medicines List 2020 [12 Aug, 2020]

Minutes of 295^th meeting of Registration Board held on 8^th to 11^th June, 2020 [07 Aug, 2020]

Minutes of 79^th Meeting of EEC held on 14^th May, 2020 [06 Aug, 2020]

Minutes of 78^th Meeting of EEC held on 23^rd April, 2020 [06 Aug, 2020]

Minutes of the 17^th Meeting of the Medical Device Board (MDB) held on 13^th July, 2020 [30 Jul, 2020]

Voluntary Recall of Herceptin Solvent Vials-20ml Batch Number: N7396B04 Due to Glass Particles in Solvent Vials [17 Jul, 2020]

Drug Pricing Policy 2018 as Ammenended Vide Notification No.F.11-2/2020-DD(P) Dated: 15 Jul, 2020 [17 Jul, 2020]

Annual Adjustement in MRPS of Drugs under paragraph 7 of Drug Pricing Policy 2018 [17 Jul, 2020]

Priority Approval/Registration of Drugs Favipiravir During the COVID-19 Pandemic [14 Jul, 2020]

Updated Members of Policy Board for Drug Regulatory Authority of Pakistan (DRAP) [10 Jul, 2020]

Provisional List Establishment Licenses issued under MDR, 2017 - Form 3, Form 4, Enlistment Import, Enlistment Local, Registration Import, Registration Local (MDMC Division) [07 Jul, 2020]

Provisional List Form 6 Local Manufacture, Form 6-A (MDMC Division) [07 Jul, 2020]

Provisional List Form 7 Local Manufacture, Form 7-A (MDMC Division) [07 Jul, 2020]

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]

Minutes of 294th meeting of Registration Board [25 May, 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]