Home > Articles by: Mughees Mudassir

Author: Mughees Mudassir

DRAP Releases 2nd Edition of Guidelines for Good Clinical Practice (GCP) Inspections

Mughees Mudassir Uncategorized

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the release of the second edition of the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS“.

These guidelines provide a comprehensive framework for all stakeholders involved in clinical research related to therapeutic goods in Pakistan.

Key Features of the Updated Guidelines:

  • Enhanced Clarity: This second edition streamlines the guidance, making it easier for sponsors, investigators, research institutions, and laboratories to understand the procedures for GCP inspections.
  • Broader Applicability: The guidelines now explicitly cover Contract Research Organizations (CROs), BA/BE Study Centers, and Bio-Analytical Laboratories involved in clinical trials.
  • Improved Transparency: The revised document clearly outlines the roles and responsibilities of both clinical research participants and DRAP inspectors during the inspection process.
  • Risk based GCP Inspections

Benefits of Following these Guidelines:

  • Ensuring Patient Safety: Adherence to GCP principles is critical for safeguarding the well-being of participants in clinical trials.
  • Promoting Research Quality: Clear communication of inspection procedures fosters a transparent and high-quality research environment.
  • Facilitating Regulatory Compliance: Understanding inspection protocols allows research entities to prepare effectively and demonstrate compliance with DRAP regulations.

We encourage all parties involved in conducting clinical research in Pakistan to download and familiarize themselves with these updated guidelines.

Download the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS”

Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

Mughees Mudassir Drugs, Licensing and Inspections ,

The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs).

Features of Revised Edition of the Guidance Document

This document provides a clear and concise overview of the entire licensing process, from initial application to post-license modifications.

The guidance document outlines the steps involved in obtaining a DML, including site selection, application forms, fee payment, and inspections. This aims to make the process more efficient and transparent for applicants.

Who Benefits

Applicants: This guideline serves as a valuable resource for pharmaceutical companies, entrepreneurs, and individuals seeking to establish or expand their drug manufacturing operations in Pakistan.

Firms: Existing DML holders can utilize this document to understand their responsibilities and procedures for post-license changes and renewals.

Investors: The streamlined process outlined in the guideline can create a more attractive investment climate for the pharmaceutical industry in Pakistan.

To access the full DRAP guidance document, please Click on “Establishment of Pharmaceutical Unit and Post License Changes”.

The revised guidelines are open for public comments until March 7, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to dir.lic∂dra.gov.pk or can be posted at mailing address, Director, Division of Drug Licensing, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

Establishment of pharmaceutical units and post licensure changesDownload

Guidelines on Standards for Establishment of Hospital Pharmacies is now open for comments.

Mughees Mudassir Pharmacovigilance

Drug Regulatory Authority of Pakistan is seeking feedback on proposed guidelines for hospital pharmacies. These standards aim to ensure consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.

The guidelines cover four key areas:

  1. Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
  2. Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
  3. Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
  4. Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.

DRAP invites you to review the proposed guidelines and share your thoughts and suggestions. Your input will be invaluable in shaping the final document and ensuring it reflects the needs and expectations of patients, healthcare professionals, and the community.

These guidelines were uploaded on the official website of DRAP on 12th of January, 2024 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. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to dir.ps∂dra.gov.pk, copying 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.

DRAP-Draft-Guidelines-on-standards-for-establishment-of-pharmacies-in-PakistanDownload

DRAP issues guidelines on Good Pharmacovigilance Practices for Product Registration Holders

Mughees Mudassir Uncategorized

Registration holders are stakeholders of pharmacovigilance who have valid registration of therapeutic goods. There are also legal obligations on registration holders to monitor the safety of therapeutic goods. Therefore, there is a need that they should have basic knowledge and understanding of pharmacovigilance activities to fulfil their legal obligations. The purpose of this guidance document is to provide a basic framework for the implementation of the pharmacovigilance programme of Pakistan and to ensure that registration holders are better equipped to monitor the safety of therapeutic goods and to detect, assess, understand, prevent and investigate ADRs/ AE and AEFI reports.

This guidelines intended to assist registration holders:

a. To develop a pharmacovigilance system and monitor the safety of therapeutic goods registered in their name;
b. Collect pharmacovigilance data, perform its assessment and accordingly submit to National Pharmacovigilance Centre (NPC), DRAP;
c. Cooperate with NPC in the performance of pharmacovigilance inspection;
d. Preparation and submission of periodic safety reports and risk management plan;
e. Design and conduct post-authorization safety studies; and
f. Detect, validate and assess signals and accordingly communicate to NPC and other stakeholders and considers options for risk minimization.

Click Here to access the guidelines.