National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.

National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.


National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Islamabad Pharmacovigilance Centre and Shifa
International Hospital, Islamabad conducted a one-day pharmacovigilance training session on 19th of May, 2022. Director and Deputy Director Pharmacy Services Division, Team Lead Vigilance and Focal Persons of National Pharmacovigilance Centre and Islamabad Pharmacovigilance Centre attended the training session.

Pharmacovigilance focal persons of public and private sector hospitals of Islamabad were trained on ADRs reporting as per Pharmacovigilance Rules, 2022. Hands-on training on collecting and filling in ADRs reporting forms and subsequent causality assessment was provided to the participants. The training was concluded with the hope of arranging further such sessions in the future.

Islamabad 19th May, 2022: One-day training session on pharmacovigilance activities for healthcare professional conducted by National Pharmacovigilance Centre, DRAP, Islamabad in collaboration with regional pharmacovigilance centre, Islamabad

DRAP issued Guidelines for Public Health Programs (PHPs) to promote Pharmacovigilance activities and enhancing collaboration with National Pharmacovigilance Centre, DRAP.

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.

The key objectives of pharmacovigilance activities in public health programs are:-

  1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
  2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
  3. To encourage the safe, rational and more effective use of therapeutic goods.

This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

DRAP published the draft of this guidelines on its website on 23rd April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidelines on the pharmacovigilance activities in the public health programs are finalized. Nevertheless, anyone can still furnish his/her comments on the guidelines using our comments submissions methods for consideration in the future editions of the document.

Please click to view the document, GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES

DRAP issues guidance on the submissions of Clinical Trials Applications

The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document provides general guidance to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline on the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials.

These guidelines will assist sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.

These guidelines explains the procedures for filing applications of clinical trials and provides an insight on the steps to be followed by the applicants. As per DRAP Act, 2012 and Drug Act, 1976 it is required that all the therapeutic goods marketed in Pakistan must have a valid authorization / registration with the Drug Regulatory Authority of Pakistan (DRAP), and any clinical trials using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.

DRAP published the draft of this guidance document on its website on 8th April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidance document on the clinical trial applications is finalized. Nevertheless, anyone can still furnish his/her comments on the guidance documents using our comments submissions methods for consideration in the future editions of the document.

Please click here to view the Guidance on Clinical Trials Applications

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country

DRAP has a regulatory oversight on import and export of all type of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws, and refuses the entry or exit of any therapeutic good in case of noncompliance to the regulatory requirements.

“Import and export of any therapeutic goods prohibited under Rule 23 of the Drugs Act 1976 and Schedule II of the DRAP Act 2012 are punishable under Rule 27 of the Drugs Act 1976 and Schedule III of the DRAP Act, 2012”

These regulatory controls are applied to prevent the infiltration of substandard and suspected falsified medicine into the supply system and to assure the access to standard quality therapeutic goods. This guidance document will elaborate the requirements, procedures for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. It covers the both import and export of therapeutic goods for commercial and non-commercial purposes, and also provides guidance on determination of the eligibility of importers and exporters.

Please click to access the final guidance document on Import and Export of Therapeutic Goods

The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.

For more information on regulatory guidelines issued by DRAP, please navigate to our section on “Regulatory Guidelines

Mr. Asim Rauf, CEO, DRAP met with WHO Country Representative, Dr Palitha Gunarathna Mahipala to promote bilateral cooperation

Mr. Asim Rauf, CEO, DRAP met with WHO Country Representative, Dr Palitha Gunarathna Mahipala to promote bilateral cooperation

Mr. Asim Rauf, CEO DRAP met with WHO Country Representative for Pakistan, Dr Palitha Gunarathna Mahipala on Monday 25th April, 2022 at WHO Country Office, Islamabad, to discuss the bilateral cooperation among WHO and Drug Regulatory Authority of Pakistan.

Dr. Mahipala appreciated the efforts of DRAP and Ministry of National Health Services, Regulation & Coordination for strengthening the national regulatory framework to ensure and enhance the access of quality assured, safe and efficacious therapeutic goods in the country for better health of the people of Pakistan. Mr. Asim Rauf, acknowledged the role of WHO and country office’ team for extending assistance in various health programs which are improving the access of Pakistani citizen to quality assured therapeutic goods.

The meeting ended with the reiteration of the commitment from WHO and DRAP for strengthening the bilateral cooperation and to take all possible measure for protecting the health of the people of Pakistan.

National Pharmacovigilance Centre, DRAP issued draft guidelines on promoting Pharmacovigilance activities in Public Health Programs (PHPs).

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.

The key objectives of pharmacovigilance activities in public health programs are:-

  1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
  2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
  3. To encourage the safe, rational and more effective use of therapeutic goods.

This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to npc@dra.gov.pk, copying at aqsa.hashmi@dra.gov.pk, or can post at mailing address, Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES

DRAP issues a guidance for Healthcare Professionals on reporting of Adverse Events to the Pharmacovigilance Centers

DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the therapeutic goods’ safety across the country. NPC has developed different reporting channels that are available through the official website of DRAP and a mobile application (MED Safety) for reporting of any Adverse Events (AE) to ensure the safety of therapeutic goods.

These guidelines details the principle requirements for Adverse Events reporting by Healthcare Professionals and provide guidance on reporting channels available to the Healthcare professionals for AE reporting. HCPs are responsible for the timely identification, documentation, and reporting of AEs and their contribution is essential to the early detection and reporting of an AE. The purpose of this document is to. –

  1. Guide and enlighten HCPs about reporting AEs to NPC, DRAP;
  2. To enhance the participation of HCPs in the reporting system of the country; and
  3. To develop a spontaneous reporting culture in the country to ensure therapeutic good’s safety.

Click to view the guidance document of ADVERSE EVENTS REPORTING GUIDELINES FOR HEALTHCARE PROFESSIONALS

DRAP seeks comments of stakeholders on draft guidance document for Clinical Trials Applicants

The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP). The current guideline describes the regulatory requirements, procedure for submission, review, evaluation and approval of applications for the conduct of clinical trial.

These guidelines are applicable on the sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.

These guidelines will assist researchers / investigators on the procedures for filing applications of clinical trials and will provide an insight on the steps to be followed by the applicants who wish to conduct clinical trials in Pakistan. It is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan (DRAP) and any clinical trial using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to dir.ps@dra.gov.pk, copying at zeeshan.nazir@dra.gov.pk, or can post at mailing address Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document Guidelines for Clinical Trials Applications

DRAP holds meeting of provincials’ health departments and drug control organizations of all federating units to strengthen the regulatory oversight through an integrated and harmonized regulatory approach.

DRAP holds meeting of provincials’ health departments and drug control organizations of all federating units to strengthen the regulatory oversight through an integrated and harmonized regulatory approach.

Drug Regulatory Authority of Pakistan (DRAP) is continuously engaged in strengthening national regulatory framework in collaboration with all stakeholders. In this context, a meeting of regulators was convened on 1st April, 2022 at Islamabad to review the all cross cutting regulatory functions. Senior managements from Drug Control Organizations, Quality Control Boards and Drug Testing Laboratories participated in the meeting.