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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.

Draft-PRV-GuidelinesDownload

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.

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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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DRAP issued Consolidated Notification for Regulatory Fees

Asad Ullah Advertisements, Alternative Medicines, Clinical Trials, Controlled Substances, Drugs, General, Licensing and Inspections, Medical Devices, Notifications, SROs

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –

DRAP-Consolidated-Fee-17.04.2023Download

Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products

Asad Ullah Drugs, General , , ,

The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.

DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.

This draft guideline is uploaded on the official website of DRAP dated on 27th March, 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. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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Important Notice to Pharmaceutical / Biological Manufacturers and Importers

Umer Farooq Drugs

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

All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification,  in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal  to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained. It is further clarified that after the lapse of the due time for above-said activity, necessary regulatory fee may apply.

For further information and queries, Registration holders may contact Data Management Cell (DMC) of Pharmaceutical Evaluation & Registration Division through email (dmc∂dra.gov.pk) with regards to guidance for procedures and requirements etc.

Pakistan Integrated Regulatory Information Management System (PIRIMS)

PIRIMS enable the regulators and industry to communicate electronically for processing regulatory information related to licensing, registration, inspections procedures for pharmaceutical and biological drugs.

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