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Author: Mughees Mudassir

Stakeholders are invited to comment on Draft Post-registration variation guidelines for pharmaceutical and biological products (3rd Edition)

Mughees Mudassir Invitation for Comments

This is the draft for 3rd Edition of the Post-registration variation guidleines. This document is intended to provide information for submission of post registration variation application by the registrations / marketing authorization holders of drug products and includes categories of variations and the required documentation & procedures for submission of an application for a particular variation. Keeping in view of the decisions of the Registration Board, the following changes have been incorporated in this edition:

  1. Changes in Labelling & Prescribing Information and/or SmPC
  2. Standardization of formulation in accordance with the innovator’s product/ approvals of reference regulatory authorities/ pharmacopeias.
  3. Change in packaging design/color scheme of packaging material
  4. Grant of additional pack size for locally manufactured products (non-essential      drugs) (except injectables and ophthalmic preparations)
  5. Change in registration Status from finished import to bulk labelled primary pack import local secondary packing. 
  6. Change in registration status from finished import to ready-to-fill bulk/ bulk concentrate import local processing.

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.

Submit Feedback: Email comments to sanakanwal2010∂gmail.com by 15th April 2026.

Deadline for Feedback: Initial Deadline: 26th March, 2026

The timeline for submission of comments has been extended till 15th April 2026.

DRAFT-PRV-Guideline-Rev-3Download

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