The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
Month: September 2022
109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
108th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 108th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 22nd June, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
107th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 107th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2022. The detail of applications which required further information /clarification and documentation is attached hereunder for information by all stakeholders.
DRAP issued Guidelines on Management of High Alert Medication
DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.
High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM).
The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions.
This draft guideline was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.
Suggestions can be forwarded via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂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.
click to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.
National Task Force (NTF) for Eradication of Spurious and Unregistered Therapeutic goods; CEO DRAP Chaired the meeting of NTF Core Team
On 28th September, 2022; The meeting of Core Team of National Task Force for Eradication of Spurious and Unregistered Therapeutic Goods held on 28th September, 2022 at DRAP, HQ Islamabad. The Chief Executive Officer (CEO) of Drug Regulatory Authority of Pakistan (DRAP) chaired the meeting of Core Team for the National Task Force in light of the recommendation of Senate’s Standing Committee on Ministry of National Health Service, Regulation & Coordination (M/o NHSR&C) today at the DRAP Head Quarters, Islamabad. The Director of Quality Assurance & Lab Testing, DRAP, Director of Licensing, DRAP and All the Chiefs of Drug Inspectorates from across the Pakistan attended the meeting. The CEO, DRAP emphasized on enhancing the collaboration among federal and provincial inspectorate of drugs for market surveillance, ensuring the availability of life saving medicines and mitigation of shortage of medicines. The CEO, DRAP further added the measures to control overpricing and particularly the products for public health emergencies should be focused upon. Rapid Alert System for immediate eradication of substandard and falsified product posing high level threats and effective recalls of defective therapeutic goods were deliberated upon in details. Finally, the communication mechanism for National Task Force was discussed in detail and agreed upon by the participants.
DRAP issued guidance on Remote Virtual Inspection (RVI) for GMP Assessment of overseas manufacturing facilities for registration of finished Pharmaceutical Drugs and Biologicals
Minutes of 320th Meeting of Registration Board held on 29th -31st August, 2022
The Drug Registration Board convened its 320th meeting on 29th – 31st August, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
World Patient Safety Day: DRAP takes part in global health campaign on Medication Safety; NPC holds a Webinar on” Medication without Harm” on 16th September, 2022
17th September has been declared as the World Patient Safety Day, to raise awareness about Global Patient Safety Challenges with a specific theme each year. One of the basic component of patient safety is putting an end to avoidable errors within healthcare settings.
WHO has identified “Medication Without Harm” as the theme for 2022 which is the third Global Patient Safety Challenge. This campaign is aimed to propose solutions to remove the obstacles prevalent today to ensure the safety of medication practices. The objective and voice “Medication Without Harm” aims to reduce avoidable medication-related severe harms by 50% globally in the next five years. Over the years, The challenge to ensure patient safety become more complex with new technology, treatments, and medicines being introduced in healthcare systems.
DRAP invites all healthcare professionals to work together to improve patient safety and ensure use of medications without harm
How to Join Our Webinar
The National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan has scheduled an online session on 16th of September, 2022. This session is the part of the our campaign on the World Patient Safety Day 2022 with a focus on theme “Medication Without Harm”.
Topic: Medication without Harm
Date and Time: Friday 16, September, 2022 at 10:00 AM to 11:00 AM
Join using Microsoft Team
Join a Microsoft Teams Meeting by ID | Microsoft Teams
Meeting ID: 264 775 816 387 Passcode: J4tvFx
Join virtually using Microsoft team preferably 15 minutes before the start of session. Participants are advised to display their names and organization 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.
-Sessions recordings and Training Materials will be available shortly after the session.
DRAP celebrated World Patient Safety Day 2022
The National Pharmacovigilance Centre, Division of Pharmacy Services, DRAP conducted an online session on the “Medication Without Harm” campaign of the World Patient Safety Day 2022. The target audience were healthcare professionals. The topics of Medication errors in context of healthcare institutes and medication safety & role of DRAP in the perspective of patient safety and pharmacovigilance were focused on in the session. Mst. Saharish Nazar, Agha Khan University Hospital (AKHU) and Mr. Abdul Mateen Focal Person National Pharmacovigilance Centre were the speakers in the session.
Dr. Noor Muhammad Shah, Head of National Pharmacovigilance Centre gave the message that patient safety is a mutual responsibility and presence of a reporting and learning system is essential. Muhammad Asad, Depuy Director Pharmacy Services conveyed the global scenario of harm caused due to medication and the importance of patient safety in provision of healthcare.
The session ended with the expectation of a positive impact on the working and output of pharmacovigilance in the country.