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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

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