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. –
- Guide and enlighten HCPs about reporting AEs to NPC, DRAP;
- To enhance the participation of HCPs in the reporting system of the country; and
- 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
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.
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:-
- 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.
- To help achieve consistency, transparency, clarity, efficiency and high quality in both the content and management of reviews.
- 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
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
Drug Product Recall; Flagynase Suspension (Batch # 0244) by M/s. Aries Pharmaceuticals Pvt. Ltd, Peshawar.
DRAP issues guidelines on Good Pharmacovigilance Practices for Product Registration Holders
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.
Circular: Mecobalamin Manufacturing and Testing
Circular: Cefixime Capsule 200mg & 400mg Specifications.
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.
