Ministry of National Health Services Regulations & Coordination Islamabad
Ministry of National Health Services Regulations & Coordination Islamabad
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]
National Essential Medicines List 2020 [12 Aug, 2020]
Minutes of 79th Meeting of EEC held on 14th May, 2020 [06 Aug, 2020]
Minutes of 78th Meeting of EEC held on 23rd April, 2020 [06 Aug, 2020]
Minutes of the 17th Meeting of the Medical Device Board (MDB) held on 13th 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]
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]
Notification for want of information with respect to deferred products in 79th meeting of EEC held on 14 May, 2020 [16 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]
Minutes of 294th meeting of Registration Board [25 May, 2020]
Tender Document Supply/ Installation of Procurement of Desktop Computers, MFP Network Printers / Copiers & Mobile Tablet [04 May, 2020]
Advisory Reminder of Risk of Serious Side Effects with Chloroquine and Hydroxychloroquine During the COVID-19 [30 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]
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]
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]
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]
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]
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]
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]
Invitation to bid for Photocopies of Official Documents on need basis - Closing Date: February 20, 2020 [06 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]
Notification of Members of the Appellate Board [16 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]
Costing and Pricing S.R.O 09(I)/2020 [07 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]
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 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]
