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The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.

Ijaz Mustafa Drugs, General, Notifications, Pharmacovigilance , , , , , ,

Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.

Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.

The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.

According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:

  • To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
  • To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
  • To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
  • To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
  • To maintain pharmacovigilance records and documentation for at least 10 years.

“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”

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Training on Pakistan Single Window for DRAP Module

Asad Ullah Drugs, Events, Licensing and Inspections, Regulatory Updates , , ,

Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._

In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.

The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.

Interested members are requested to register themselves by clicking below:
Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g

Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.

Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021.

Asad Ullah Drugs, General, Notifications

The Ethical Marketing to Healthcare Professionals Rules have been notified vide SRO 1472(I)/2021 on the 12th of November 2021 by the Drug Regulatory Authority of Pakistan. These rules have been promulgated to make the interaction between companies and healthcare professionals transparent, free from corrupt practices and to facilitate medical decisions making in the best interest of the patient.

The aforementioned rules require therapeutic goods companies to submit marketing expenditure details under rule 14(2) and annual compliance certificate under rule 13(h). Subsequent to the notification of these rules, DRAP has drafted an implementation strategy which requires systematic data submission.

The implementation strategy is aimed at harmonized data submissions by stakeholders in a systemic manner, we have drafted followings formats for data submission:-

Comments from therapeutic goods companies, healthcare professionals and relevant stakeholders are invited on the draft documents within 15 days. These comments along with justification are to be submitted using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to drap.pharmacy∂gmail.com, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Islamabad.

Stakeholders Comments are invited on Draft Guidelines for Post-Registration Variation of Drugs

Asad Ullah Drugs

DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle. These guidelines retain the essentials of the previously published guidelines and have been extended with new terminology of types of variations and documentation required to support a specific change.

This guideline is intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

This guidance document is applicable to APIs and excipients manufactured by chemical synthesis or semi-synthetic processes and biological processes and the drug products containing such APIs & excipients.

These draft guidelines on post registration variation were uploaded on the official website of DRAP on 4th July, 2023, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to  muneeb.cheema∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmaceutical Evaluation & Registration  4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs.

Ijaz Mustafa Drugs, General, Regulatory Updates

Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-

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Updated Database of Pharmaceutical and Biological Drug Product

Asad Ullah Drugs, Regulatory Updates

The Drug Regulatory Authority of Pakistan (DRAP) has updated the database of pharmaceutical and biological drug products. This database is available for public access through DRAP Website and contain information on the drugs registered by the DRAP including the Name of Product (brand/proprietary name), Dosage Form, Composition / Active ingredients, Registration Number, Registration Date, Market Authorization holder and Manufacturing company.

Search Registered Drugs

The publicly accessible version of this database is for reference purposes only and is subject to a disclaimer. It provides information on the registered pharmaceutical and biological drug products that can be supplied through authorized establishments (pharmacies/retail outlets or healthcare institutions) in Pakistan.

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Note: This database reflects the record of the contents available with the respective Divisions of DRAP. It is not intended to provide any guidance, advice or recommendations on these products.

Unless exempted through special permissions, any pharmaceutical or biological products that is not registered with DRAP cannot be imported or supplied in Pakistan.

For Market Authorization Holders:-

DRAP has transformed manual operation to PIRIMs, marketing authorization holders of pharmaceutical and biological drug products are requested to review and update their finished products Specifications. In this context, a notice was issued and uploaded on the website of DRAP on 13th March, 2023 and 20th April, 2023 (link), with the direction to all Registration Holders of pharmaceutical and Biological drug products to update finished products Specifications. The requisite information must be provided before 09th June, 2023.

DRAP invites Comments on Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use

Asad Ullah Drugs, News & Updates, Regulatory Updates

This guidance is developed to assist manufacturers and importers in developing their applications for registration of human biological drug products. Drug Regulatory Authority of Pakistan (DRAP) has adapted CTD format for registration of all such drugs vide SRO-713(l)/2018 dated 8th June 2018. Detailed guidance regarding the data requirement for CTD format has been provided in ICH M-4 guidelines. Since the DRAP is introducing the CTD in a progressive manner, therefore, initial guidance to applicants would be helpful for harmonization and appropriate data submission to achieve consistency and uniformity of application.

The guideline is intended to provide data requirements of Form-5F (CTD) for registration / market authorization of biological products of all types including New drug products, and Biosimilars. This document provides guidance for importers and local manufacturers of human biological products on how to obtain market authorization / registration in the territory of Pakistan.


This draft guideline is uploaded on the official website of DRAP dated on 9th May, 2023, 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 a ahmad.ansari∂dra.gov.pk copying at ahsan.hafiz∂dra.gov.pk , or can be posted at mailing address,  Director, Biological Drugs, Drug Regulatory Authority of Pakistan, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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DRAP issued a Draft of Guidelines on the Lot Release of Biological Drugs

Asad Ullah Drugs, General

The lot release of biological products is a part of the regulation of biological products. It involves the independent assessment of each lot of a licensed biological product before it is released in the market. In addition to manufacturing, the complexity inherent to biological products, proper storage conditions and efficient supply chain management must be ensured to preserve these products’ sensitivity and limited shelf life properties. For the reasons stipulated above, a careful independent review of manufacturing and quality control data on every lot of product as stated is, therefore, necessary before use. Lot release program enables National Regulatory Authority (NRA) to ascertain the safety, quality, and effectiveness of every lot of these products.

This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, 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 the prescribed format, (further information on comments submission can access at this link. Comments and suggestions can be forwarded via email to ayub.naveed∂dra.gov.pk, copied at director∂nclb.dra.gov.pk, or can be posted at the mailing address, The Director, National Control Laboratory for Biologicals, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Chak Shehzad, Islamabad.

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Compliance to the Notice Dated 13-03-2023 with Regard to Specifications and Data related Activity in PIRIMS

Umer Farooq Drugs, General

DRAP has deployed an online application management system “Pakistan Integrated Regulatory Information Management Systm (PIRIMS)” ‘ for processing of regulatory information related to licensing, registration, and inspections of pharmaceutical and biological drugs.

Transforming manual operation to PIRIMs, DRAP requested marketing authorization holders of pharmaceutical and biological drug products to review and update their finished products Specifications. Accordingly, a notice was uploaded on the website of DRAP on 13m March, 2023, with the direction to all Registration Holders of pharmaceutical and Biological drug products to update finished products Specifications and validated method of testing i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRMS at http://pirims.dra.gov.pk.

The timeline for submission of requisite information on the PIRIMS has been further extended till 09th June 2023 on the request of pharmaceutical industry.

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