Lahore – October 21-22, 2024: The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the World Health Organization (WHO) Pakistan, hosted a provincial workshop on the implementation of Institutional Developmental Plans (IDPs) aimed at strengthening the National Regulatory System of Pakistan based on WHO recommendations.
Mr. Nadeem Mahbub, Federal Secretary of the Ministry of National Health Services, Regulation & Coordination, and Ms. Ellen Mpangananji Thom, Officer Incharge, WHO Office in Pakistan participated in this workshop.
Mr. Asim Rauf, CEO DRAP briefed the participants on the roadmap for strengthening the regulatory system of Pakistan.
This interprovincial coordination workshop was attended by key officials, including the Director General of Provincial Drug Control Administrations, the Chief Inspector of Drugs from all federating units, Directors of National Quality Control Laboratories (CDL and DTLs), officers from provincial regulatory institutions, and teams from DRAP working on the implementation of the Institutional Developmental Plans (IDPs) based on the WHO Global Benchmarking Tool for National Regulatory Authorities.
This 02-day workshop provided the opportunities to strengthen the regulatory framework in all federating units by developing collaborative working procedures in various areas including pharmacovigilance, Market Surveillance, Licensing, Inspection, Laboratory Testing and Quality Management System.
The Drug Regulatory Authority of Pakistan held an insightful discussion on “Building Effective Medicine Pricing Policies for Low and Middle-Income Countries on Tuesday July 23, 2024 at 10:00 AM at DRAP HQ, Islamabad. The session was led by Prof. Zaheer-Ud-Din Babar, University of Huddersfield and Editor-in-Chief of the Journal of Pharmaceutical Policy and Practice. Senior management of the DRAP attended the session at DRAP HQ, Islamabad, while more than 100 colleagues from industry and academia participated in the session virtually.
The discussion among participants centered on evidence-based challenges and potential solutions for medicinal pricing policies, tailored to the specific needs of low and middle-income countries. It included an analysis of five distinct pharmaceutical pricing strategies and the primary enablers for developing effective policies.
In case you missed the live session, the webinar recording is available at the following link.
World Health Organization (WHO) has developed a Guidance on Good Manufacturing Practice (GMP) for Blood Establishment to ensure the safety and quality of blood products with the aim to strengthen the technical capacity of National Regulatory Authorities (NRAs) for implementing the appropriate control of blood products. This GMP webinar will explain GMP principles and concepts comprehensively.
Drug Regulatory Authority of Pakistan (DRAP) invites healthcare professionals and stakeholders working in the blood establishments to attend/participate in the World Health Organization (WHO) webinar on “Good Manufacturing Practice (GMP) for Blood Establishment from 7 to 10 May 2024.
The SCO conference on the development of medical and pharmaceutical cooperation was held in Suzhou, China on September 25, 2023. The conference was attended by representatives from the public and private healthcare sectors of the Islamic Republic of Iran, the Republic of Kazakhstan, the People’s Republic of China, the Kyrgyz Republic, the Islamic Republic of Pakistan, the Russian Federation, and the Republic of Uzbekistan.
Mr. Asim Rauf, appreciated the organization of this significant event, which plays a crucial role in promoting regional cooperation and development in the pharmaceutical sector. He added that the SCO region holds immense potential for enhancing pharmaceutical collaboration, and we are committed to contributing to this shared vision. The platform of SCO offers an excellent opportunity to share insights, learn from each other’s experiences, and work collectively towards a safer, more accessible, and sustainable pharmaceutical landscape.
The pharmaceutical industry in Pakistan is evolving from its modest beginnings to become a significant contributor to our national economy as well as meeting around 80 % of domestic needs. Pakistan is eager to collaborate with our fellow SCO member states to harness the full potential of the pharmaceutical sector.
Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._
In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.
The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.
Interested members are requested to register themselves by clicking below: Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g
Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.
National Medicine Policy is a high-level guiding document that outlines the national perspective and strategies to promote health sector for enhancing national capacities with the aim to increase access to and rational use of high quality and affordable medicines and health products in the country.
DRAP has significance role in the development and implementation of National Medicine Policy. As a country, we need to undertake measures to make drugs accessible to our populations and future generations through ensuring high-tech manufacturing capabilities, their proper distribution and having trained professional workforce to prescribe and administer these drugs. With the growing population, our needs for essential drugs are also growing for treating various diseases. To meet the objective, a holistic approach is needed in which all the stakeholders work for ensuring that patients get access to quality assured, safe and effective drugs.
TWG Meeting on National Medicine Policy, 1-2 Aug, 2023 at Islamabad
A National Medicine Policy is a crucial framework which provides strategic directions and guidelines for safe, effective, and accessible use of drugs within a country. It has huge significance as it impacts the public health directly. A well-developed NMP ensures equitable access to essential medicines and contributes to disease management and control.
The ISPE Annual Conference & Exhibition, 2023 for Pharmaceutical and biomanufacturing professionals is happening from 23-25 August, 2023 at Suntec, Singapore & online. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.
The conference is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.
lSPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023
Free Registration for Regulators, Pharma and Biomanufacturers
The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for regulators and industry professionals who can get register for free to attend the ISPE Singapore conference in august, either online or in person.
Interested applicants are required to fill out the google form provided on the this link or by open the below the link in the browser https://www.cognitoforms.com/ISPESingapore1/ISPESingaporeConferenceExhibition2023ComplimentaryDelegatePass Please note that these complimentary delegate passes are subject to approval by the organizer and may be limited;
National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.
The workshop focused on the following key objectives:
Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
Emphasizing the need and importance of Recall and Rapid Alert System.
Training and building capacity of all the participants.
Enhancing coordination and communication with provincial governments and related departments.
Safe disposal system of SF products
Improvement in DRAP’s guidelines and harmonization with International best practices.
Risk Communication flow chart for handling SF threats
Core Activities and Topics Covered
1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.
2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.
3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.
4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion.
5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.
6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets.
7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.
8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.
Access, Watch, and Reserve (AWaRe) classification was introduced by the World Health Organization in 2017 for strengthening antibiotic stewardship and controlling antimicrobial resistance at the national level. This also includes in WHO GPW 13 indicators of antibiotic use. AWaRe is a relatively “easy” tool that offers more than overall antibiotic use or more conventional classifications.
WHO country office, in Pakistan, has been facilitating the development of Pakistan’s first “Evidence-based AWaRE classification of essential antibiotics” online active engagement of stakeholders. In the past two years, national experts in the field and consultants were engaged on multiple occasions through online and face-to-face meetings to develop the needful tools, formulate a comprehensive desk review, and collect the indigenous AMR data with support of NIH. The first consultative meeting of the process was held on 29th April 2021 and was attended by more than twenty participants from federal, and provincial levels with representation from both public and private sector.
Drug Regulatory Authority of Pakistan in collaboration with Ministry of National Health Services, Regulation and Coordination convened the final consultative meeting for development of the AWaRe classification of antibiotics for Pakistan. The meeting participants included the representatives from the M/o NHSR&C, DRAP, World Health Organization, National Institute of Health, Healthcare Commissions and National AMR surveillance program leads at federal and provincial levels, and the AMR sentinel sites. Leading national experts from the field of microbiology, infectious diseases, and other specialties including pharmacists, nurses, academicians, and public health professionals and epidemiologists were invited to ensure maximum contribution from the stakeholders.
The developed list will act as a guiding principle for designing institutional antibiotic policies and act as a stepping stone to achieve control of the growing antimicrobial resistance in the country.
