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

Asad Ullah Events, Press Releases
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.

DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country

Ijaz Mustafa Regulatory Updates, SROs

The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).

The Pharmacovigilance Rules,2022 are aimed at :-

  • Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
  • Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
  • Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
  • Better communication and collaborative working among all stakeholders.

To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”

SRO-540I-2022-PV-Rules-2022Download

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

Asad Ullah Regulatory Updates

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 asks stakeholders to comment on the draft guidelines on Bio-availability & Bio-equivalence studies for generic drug products

Yasir Mahmood Drugs, Regulatory Updates

The Drug Regulatory Authority of Pakistan (DRAP) ensures that all pharmaceutical drug products conform to acceptable standards of safety, efficacy and quality. This guidance will be applicable to orally administered generic drug products as well as to non-orally administered pharmaceutical products for which systemic exposure measures are suitable for documenting bioequivalence.

This document will provides guidance to the industry for in vivo and in vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product.

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 abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the “Draft Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products”

Stakeholders comments are invited on draft Guidelines for Labeling & Packaging of finished drug products.

Yasir Mahmood Drugs

This guidelines are aimed to assist industry (marketing authorization holders) in drawing up the label and package leaflet for their products in compliance with the Drugs (Labelling and Packing) Rules 1986. This documents will provide specific requirements for the labelling and packaging of pharmaceutical and biological drug products.

The purpose of the guidelines are:-

  1. To provide guidance on how to ensure that the information on the label and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine or ensure its use safely and appropriately.
  2. To help achieve consistency, transparency, clarity, efficiency and high quality in both the content and management of reviews.
  3. This guideline is written to assist applicants and marketing authorization holders when drawing up the label and package leaflet

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 abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document Draft Guidelines on Labelling and Packaging of Drug Products

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

Asad Ullah Clinical Trials

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