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National Pharmacovigilance Center Convened one-day Training Session for Clinical / Hospital Pharmacist and Pharmacovigilance Officer at Rawalpindi Medical University

Asad Ullah Events

National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Holy Family Hospital, Rawalpindi Medical University conducted a one-day pharmacovigilance training session on 20th July, 2022 at Rawalpendi Medical University for Clinical Pharmacy and Pharmacovigilance Officers and Hospital Pharmacists of the public sector hospitals of the Rawalpindi Division.

Dr Noor Muhammad Shah, Director Division of Pharmacy Services (Head of National Pharmacovigelance Centre), Mr. Abdul Mateen, Assistant Director Pharmacy Services (Focal Person National Pharmacovigilance Centre), Mst. Aqsa Hashmi, Assistant Director Pharmacy Services and Mst. Nazima Asghar, Clinical Pharmacy and Pharmacovigilance Officer, Holy Family Hospital gave detailed presentations in the subject matter.

Medical Superintendent and Drugs Controller of Holy Family Hospital and Professor/HOD of Pharmacology Department along with her team from Rawalpindi Medical University also joined the session. Participants from Holy Family Hospital, Rawalpindi Institute of Cardiology, Benazir Buttto Hospital, Rawalpindi Institute of Urology and Transplant and Tehsil Headquarters hospitals of Murree, Taxila, Gujar Khan, Kallar Syedan, Kotli Sattian were trained by the above team of trainers from DRAP and Holy Family Hospital on different aspects of pharmacovigilance such as the establishment of pharmacovigilance centre, collection of data and subsequent reporting to the provincial pharmacovigilance centre of the Punjab. The training was concluded by the Head of the National Pharmacovigilance Center by highlighting the imminent points of the presentations with the hope that the session will bring significant improvement for establishment of Pharmacovigilance Centers and reporting of ADRs accordingly.

Policy for Inspection of Manufacturing Site Abroad

Asad Ullah Drugs, News & Updates, Notifications, Regulatory Updates

Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) has given policy guidelines for inspections of manufacturers keeping in view the suggestions/guidelines of WHO for reliance on other regulatory authorities. Accordingly, the revised “Policy for inspections of manufacturers abroad” as approved by the Policy Board under Section 11 (I) (a) of the DRAP Act, 2012, as under:-

Current-Policy-fo-inspectionDownload

DRAP notified National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules, 2022

Asad Ullah Notifications, Pharmacovigilance, Press Releases

Drug Regulatory Authority of Pakistan (DRAP) , in pursuance to the enactment of Pharmacovigilance Rules, 2022 has notified the National Pharmacovigilance Centre, with the aim to further enhance the Pharmacovigilance activities includes collecting, analyzing, monitoring, and preventing adverse effects in the therapeutic goods.

DRAP also encourages all healthcare professionals to establish the practices of pharmacovigilance in the country as they have pivotal role in monitoring the safety and efficacy of therapeutic goods, particularly for newly-marketed product.

NPC-Notification-10.06.2022Download

The Authority, under Rule 3(1) read with Rule 3 (2) of the Pharmacovigilance Rules, 2022, notified the National Pharmacovigilance Centre under the Division of Pharmacy Services, DRAP.

The safe use of drugs, vaccines, medical devices and other therapeutic goods medicines is the most important criteria for DRAP to protect the public health and integrity of national healthcare system. Pharmacovigilance is the mechanisms to map and ensure the safety of therapeutic goods throughout their life span – from clinical trials to patient or consumer.

The importance of Pharmacovigilance is increased further in the current era due to arrival of novel of biopharmaceutical products and innovative technologies in healthcare practices.

National Pharmacovigilance Center (NPC) is working at DRAP and Pakistan is a full member of the WHO Programme for International Drug Monitoring.

Two Provincial Pharmacovigilance Centres in Punjab and Islamabad are also working in addition to a Centre of EPI (immunization programme), collecting ADR data and collaborating with the National Centre. National Pharmacovigilance Centre (NPC) has also established a Pharmacovigilance Risk Assessment Expert Committee (PRAEC).

NPC is Coordinating with other provinces/administrative territories, PHPs for establishment of their PV centers and also communicating with manufacture and importers of therapeutic goods for establishment of their pharmacovigilance system and reporting of ADRs to DRAP.

NPC has also published various documents and Guidelines for Stakeholders on pharmacovigilance activities, including :-

  1. Pakistan National Pharmacovigilance Guidelines
  2. Good Vigilance Practice Guidelines for Pharmaceutical Companies
  3. Pharmacovigilance Guidelines for Healthcare Professionals
  4. Pharmacovigilance Guidelines for Patients Pharmacovigilance
  5. Guidelines for Public Health Programmes.

Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;

Asad Ullah Drugs, Legislation, Licensing and Inspections, Regulatory Updates, SROs ,

The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.

The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.

DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.

Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

SRO 778 (I)/2022 dated 10th June, 2022

SRO-778-of-2022-PIC-GMPDownload

National Pharmacovigilance Centre, DRAP intends to seek comments of Stakeholders on “Draft Guidelines on High Alert Medication Management”

Asad Ullah Pharmacovigilance, Regulatory Updates ,

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 prepares and 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.

NPC, DRAP has recently published a revised list of High Alert Medication on the official website and is currently developing a Guidelines on High Alert Medication Management.

This document is intended for the guidance and support of hospitals and healthcare professionals (HCP) for safe prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in 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 is uploaded on the official website of DRAP dated 16th June, 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, (further information on comments submission can be accessed on this link). Comments and 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 here to view the draft Guidelines on High Alert Medication Management (Edition 01)

Decisions of 47th meeting of Medical Device Board Meeting; Deficiency letter

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 47th meeting has deferred the 271 applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board, in the below attachment.

List-Deferred-Cases-of-MDB-47-Meeting

DRAP invites comments of stakeholders on the draft Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products

Ijaz Mustafa Drugs, Publications, Regulatory Updates ,

Distribution of drug products includes all activities consisting of procuring, storage / holding, supplying, importing, and / or exporting of products. Such activities are carried out by the marketing authorization /registration holder including manufacturers/importers or their authorized distributors, which supply products to the pharmacies/licensed drug sale outlets and healthcare institutions which are entitled to dispense drug products.

Good Distribution Practice (GDP) is the set of standards of quality assurance for sourcing, handling, storage, and transportation of pharmaceutical and biological drug products under appropriate conditions, as required by the marketing authorization (MA) / registrant, or product specifications. To maintain the quality of pharmaceutical and biological products, every activity in the supply chain and distribution network should be carried out according to the principles of Good Distribution and Storage Practices.

These guidelines are drafted to provide appropriate systems and structures to assist manufacturers, distributors and wholesalers in fulfilling their responsibilities of planning and conducting various activities in the distribution and supply chain, which will be helpful in prevention of proliferation of unauthorized/unregistered, substandard and falsified products in the market.

This draft guideline is uploaded on the official website of DRAP dated 28th May, 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, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the draft Guidelines-on-Good-Distribution-PracticesDownload