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Regulatory Updates

DRAP invites Comments on Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use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

Draft-Guidance-document-of-Biological-productsDownload

Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet

Asad Ullah General, News & Updates, Notifications, Regulatory Updates ,

The Patient Information Leaflet (PIL) provides essential information to patients and caregivers on the use of drug products ensuring their safety, efficacy, and quality. It describes the information for patients that ensures the safe and effective use of medicine under most circumstances. The PIL is a document that is updated as new data emerges related to drug product safety, efficacy, and quality or use. The registration/market authorization holder is responsible shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of PIL.

The guideline is intended to provide supportive information for preparing a Patient Information Leaflet (PIL) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars. This guideline provides advice on the principles of presenting information in the PIL.

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. For further guidelines on submitting comments, visit DRAP website or click here. Comments and suggestions can be emailed to haseeb.tariq∂dra.gov.pk, copied at addl-dir.pe.reg∂dra.gov.pk, or posted at the mailing address, Director, Pharmaceutical Evaluation & Registration, Drug Regulatory Authority of Pakistan, 4th-floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

PIL-Guidelines-DRAPDownload

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.

final-draft-guideline-for-lot-release-NCLB-dated-3-5-2023Download

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.

Extension_in_timeline_for_compliance_of_FPS__STM1Download

DRAP issued Consolidated Notification for Regulatory Fees

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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

Decisions of 56th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 56th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

Applications for Local Manufacturing

Defered-Letter-of-56th-Meeting-of-MDB-LocalDownload

Applications for Import

Defered-Letter-of-56th-Meeting-of-MDB-ImportDownload

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.

Draft_Guidance_on_Cold_Chain_Practices_FormattedDownload

Decisions of 55th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 55th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

Applications for Registration of Medical Devices for Local Manufacturing

Deffered-letters-M-55-LocalDownload

Applications for Registration of Medical Devices for Import

Deffered-letters-M-55-ImportDownload

Decisions of 54th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 54th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

Deferred-MDB-54Download