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Public Consultation: Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.

Yasir Mahmood Drugs , ,

The Drug Regulatory Authority of Pakistan (DRAP), Division of Biological Evaluation & Research, invites public comments on the draft “Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.”

This updated guidance aims to enhance clarity, align regulatory requirements with international standards, and introduce specific provisions for biosimilars, bulk/ready-to-fill biologicals, pharmacovigilance, stability, and comparability requirements. The document is intended to facilitate consistent, transparent, and efficient submission and review of registration applications for biological products.

Stakeholders, including manufacturers, importers, healthcare professionals, academia, and the general public, are encouraged to review the draft and submit written comments, suggestions, or technical inputs at muneeb.cheema∂dra.gov.pk or muneebcheema∂hotmail.com within fifteen days of uploading of above document.

Guidance-Document-Biological-Edition-2Download

Recent Policy Updates and Procedural Guidelines for Drug Registration and Processing

Yasir Mahmood Drugs
  1. Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
  2. Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​
  3. Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
  4. Quality-Based Incentivisation of Applications for Local Manufacturers​
  5. Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals

Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.

Streamlining-The-Evaluation-and-Processing-of-Form-5F-Common-Technical-Document-Applications-Under-S.R.O.-713I2018Download

Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​

Submission-of-Summary-of-Product-Characteristics-SmPC-And-Patient-Information-Leaflet-PIL-Along-with-CTD-Dossier-Form-5-F._Download

Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.

Borrowing-of-APIS-for-Performing-Product-Development-R-D-and-Stability-Testing-Registration-Board-Decision-Thereof.Download

Quality-Based Incentivisation of Applications for Local Manufacturers​

Quality-Based-Incentivisation-of-Applications-for-Local-Manufacturers_Download

Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals

Revised-Policy-for-Registration-and-Enlistment-of-Formulations-Containing-Vitamins-and-MineralsDownload

Stakeholders are invited to comment on Draft Guidelines on Emergency Use Authorization by 06th June, 2025

Mughees Mudassir Drugs, General

Draft Guidelines on Emergency Use Authorization

The Drug Regulatory Authority of Pakistan (DRAP) has developed a draft guideline outlining the regulatory framework for granting Emergency Use Authorization (EUA) of medicinal products during a declared Public Health Emergency (PHE). This guideline aims to facilitate timely access to critical medicines, vaccines, or diagnostics when no approved alternatives are available, ensuring public health protection while maintaining rigorous safety and efficacy standards.

Key Highlights of the EUA Guideline

  • Legal Basis: EUA is granted under the Drugs Act, 1976 and Drug (Licensing, Registering & Advertising) Rules, 1976, empowering DRAP to authorize unregistered products during emergencies.
  • Risk-Benefit Assessment: Authorization considers whether the potential benefits outweigh risks in diagnosing, treating, or preventing life-threatening conditions.
  • Scope: Applies to emergencies involving threats to public health, safety, or national security (e.g., pandemics, bioterrorism).
  • Alignment with Existing Guidelines: Should be read alongside DRAP’s Guidance Documents for Registration of Pharmaceutical & Biological Products.

Call for Stakeholder Input

DRAP invites healthcare professionals, pharmaceutical manufacturers, researchers, policymakers, and the public to review the draft guideline and provide constructive feedback. Your expertise will ensure the framework is robust, transparent, and aligned with international best practices.

How to Submit Comments

  1. Download the Draft Guideline: https://www.dra.gov.pk/wp-content/uploads/2025/05/DRAP-EUA-Guideline-2025.docx
  2. Submit Feedback: Email comments to muneeb.cheema∂drap.gov.pk by 06th June, 2025.

Deadline for Feedback: 06th June, 2025

Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

Asad Ullah Drugs, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Implemenation letter of Industry e-reporting systemDownload

Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Asad Ullah Drugs

Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

It is hereby circulated for compliance and information of all stakeholders.

CIRCULAR-SmPC-PILDownload