News & Updates
Asim Rauf, CEO DRAP represented Pakistan in the 2nd Meeting of the Heads of National Medicine Regulatory Authorities (NMRAs) of the Member States of the Organization of Islamic Cooperation, (OIC)
The Second meeting of Heads of National Medicine Regulatory Authorities (NMRAs) held on September 05-07, 2022 in Istanbul, Türkiye. Mr. Asim Rauf, CEO DRAP and Dr. Obaidullah, Director, DRAP represented Pakistan in the meeting.
More than 40 member states participated in the meeting and adopted OIC Action Plan to promote collaboration among OIC NMRAs for access to safe, effective and quality medicines and vaccines in OIC Member States, 2022-2024.
The Action Plan includes eight objectives, among others, to strengthen cooperation and networking among NMRAs in OIC Member States, to develop the capacity of human resources and to establish and strengthen regional and sub-regional harmonization and networking among OIC countries.
The Meeting also adopted Istanbul Declaration, which included the recognizing of the challenges posed by the COVID-19 pandemic.
Director General, Department of Drug Administration (DDA), Government of Nepal with a delegate visited DRAP HQ to foster mutual cooperation
An official delegate from Department of Drug Administration (DDA), Ministry of Health & Population, Government of Nepal under the leadership of Mr. Bharat Bhattarai, Director General, DDA visited DRAP HQ, Islamabad on Tuesday, August 23, 2022. Mr. Asim Rauf, CEO DRAP warmly welcomed the Mr. Bhattarai and other senior officials from DDA and MoH, Nepal.
Directors of Division of Pharmaceutical Evaluation & Regisatrion (PE&R), Medical Devices and Medicated Cosmetics (MDMC), and Health & OTC Products (H&OTC) demonstrated their respective presentations on the various regulatory functions of DRAP. The delegates shows keen interest in the journey of Pakistan toward successful implementation of WHO/ICH Common Technical Document (CTD) format for registration of pharmaceutical and biological drugs in Pakistan, and praises the IT Systems establish by DRAP for integrated regulatory data management in the country.
The officials of the international Health Partner, United States Pharmacopeia- Prompting Quality of Medicine Plus, from Nepal and Pakistan, were also present in these meetings.
National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 02) seeking comments from stakeholders
DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the safety of therapeutic goods across the country. NPC is working with National and International coordination for the development of a functional Pharmacovigilance system in the country. Since 2018, Pakistan is the Full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre (UMC), Sweden.
The NPC has developed multi channel reporting system, including electronic and manual reporting forms supported with the guidelines that are available through the official website for stakeholders. With the promulgation of Pharmacovigilance Rules, 2022, it is now the legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.
The 1st Edition of National Pharmacovigilance Guidelines were published in October, 2019. This is the draft for 2nd Edition of National Pharmacovigilance Guidelines, being revised in the light of recently enacted Pharmacovigilance Rules, 2022. This Guidance document is intended to assist all pharmacovigilance stakeholders i.e. Healthcare professionals, Marketing Authorization Holders, Healthcare providing institutes, Patients and caregivers, etc., in playing their roles and responsibilities in the national pharmacovigilance system. The WHO Pharmacovigilance indicators have been incorporated in the chapter 11 of the draft 2nd edition to harmonize the procedure performance evaluation with international standards.
These guidelines are uploaded on the official website of DRAP on 24th of August, 2022 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to npc∂dra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Please click here to view the draft document National Pharmacovigilance Guidelines 2022
DRAP and Islamia University of Bahawalpur (IUB) signed a Memorandum of Understanding (MoU) to promote scientific Collaboration
The Drug Regulatory Authority of Pakistan (DRAP) and Islamia University of Bahawalpur (IUB) undergoes in a Memorandum of Understanding on August 19, 2022. A brief ceremony was organized at DRAP HQ, Islamabad where Mr. Asim Rauf, CEO, DRAP and Dr. Athar Mahboob, Vice Chancellor, IUB signed the MoU on behalf of their respective institutions. Senior members of both organizations were also present on this occasion.
Both organizations, Under this MoU has agreed to facilitate cooperation in academic research to fosters collective efforts in facilitating scientific progress through exchange of knowledge and expertise. It will open new opportunities for academic, research, trainings and mutual collaborations.
Training Sessions on Regulatory Data Standards for Manufacturers at Karachi and Lahore
Regulatory Data standard help Regulatory Authorities and Pharmaceutical Manufacturers for efficient exchange of regulatory data which ultimately reduces the processing time by avoiding clarifications due to variation in terminologies. These standards also facilitate data sharing between regulators and manufacturers in better understandable way, through both manual and electronic means, in a harmonized and consistent manner that is interoperable across the globe.
DRAP, in collaboration with United States Pharmacopeia, Promoting the Quality of Medicines Plus Program, is organizing a series of training sessions for regulators and industry on the regulatory data standards .The details of sessions are:
| Sr | Session Title | Date | No. of Participant* (approx) |
|---|---|---|---|
| 1 | Training on Regulatory Data Standards for Pharmaceutical Manufacturers | 19th August 2022 at Karachi. | 30 |
| 2 | Training on Regulatory Data Standards for Pharmaceutical Manufacturers | 22nd August 2022 at Lahore. | 30 |
Stakeholder associations (i.e Pakistan Pharmaceutical Association (PPMA), and Pharma Bureau) are requested to share nominations of technical and regulatory workforce for each training by 16th August 2022 positively. Nominated person can register themselves free of cost by filling out the following registration form at the earliest.
*Please note that :-
Registration will be granted on first come first serve basis.
only one participant from each manufacturer can join the session onsite.
After the completion of first 30 registration for onsite participation for each session, virtual link will be provided to the remaining registrants.
Registrations are closed now.
How to join Session Virtually:-
Those participants who submitted registration forms for the training sessions can join virtually using Microsoft team. Virtual participants are requested to join 15 minutes before the start of session, and advised to display their Names and Organizations while joining the session. Please keep your mic and camera off after joining the session. If you wish to ask a question from the presenter, please click the icon to show raise hand, and turn your mic and camera on while asking a question from the presenter.
Join using Microsoft Team
Join a Microsoft Teams Meeting by ID | Microsoft Teams
Meeting ID: 251 494 560 025 Passcode: p2MTFn
Time: 10:00 AM to 03:30 PM
-Sessions recordings and Training Materials will be available shortly after the session.
-E-Certificate will be issued to training participants after completion of feedback survey form that will be sent to them via email.
Invitation to bid (For Stationery & other Miscellaneous Items)
Training on Pharmacovigilance Module (AEFI/PV) in the Pakistan Integrated Regulatory Information Management System (PIRIMS)
Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the United States Pharmacopoeia (USP), Promoting Quality of Medicine Plus Program, Pakistan, conducted a one-day pharmacovigilance training session for the staff of the National Pharmacovigilance Centre on the newly introduced Pharmacovigilance (PV) Module in Pakistan Integrated Regulatory Information Management System (PIRMIS) on the 29th of July, 2022.
Dr Noor Muhammad Shah, Director of Division of Pharmacy Services (Head of National Pharmacovigilance Centre) along with his team of Additional Director, Deputy Director and Assistant Directors, Pharmacovigilance Centres, Division of Pharmacy Services participated in the training session. A team of USP facilitated the training session and the technical input and training was conducted by Mr Tayyab, PIRIMS Consultant-PQM+. The PIRMIS management system facilitates the submission of data by the registration holders and would be helpful in the quick disposal of work. The new PV Module has been introduced in the PRIMIS to facilitate the submission of pharmacovigilance data by registration holders as per Pharmacovigilance Rules, 2022.
Bob Tribe, TGAs former GMP Chief, assists DRAP for Strengthening of Inspection System towards harmonized PIC/s GMP Standards
DRAP aims at harmonization of Inspection system and procedures in the field of Good Manufacturing Practices (GMP) for drugs, and quality system for inspectorate, comparable with the best international regulatory practices. In this regard, Mr. Robert Wayne Tribe, TGAs former GMP Chief is providing Consultation to DRAP for progress toward PIC/s membership.
Mr. Bob served as Chief GMP at the Australian TGA for 23 years, has a hand in creating many of the GMP requirements. He is regarded as true GMP expert and consults to many GMP regulators around the world, assisting them reach the PIC/S level of regulatory control. Bob’s also served as Deputy Chairman of the PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. During his recent visit in Pakistan, he conducted observed GMP Audit and various consultative sessions with the regulators, Inspectors, industry and senior management of DRAP to discuss the current level of GMP Inspection System and is advising on gap assessment of inspectorate system to be harmonized with the PIC/s GMP Standards. A training session was also organized for DRAP’s staff on PIC/s background information for the Applicant Authorities, PIC/s GMP requirements and inspection approach.
CEO, DRAP highly appreciated the efforts of Mr. Bob for extending his services to DRAP to further strengthening and harmonization of inspection system of Pakistan at par with the PIC/s Standards. DRAP is fully committed to undertake all measures to ensure consistent supply of standards quality therapeutic goods for the people of Pakistan.
An interactive Session of Academia and Regulators on Healthcare Research and Collaborative Role
Am interactive session on healthcare research, ethical practices and collaborative role of academia and regulators was arranged at DRAP HQ, Islamabad on 26th July, 2022. A renown academician, Prof.Dr. Zaheer ud din Babar, Professor in Medicines and Healthcare, Department of Pharmacy, School of Applied Sciences, Director, Pharmaceutical Policy and Practice Research Centre, University of Huddersfield, presented his expert views on the topic and led various discussions with regulators.
