Certificate Course in Drug Regulatory Affairs (Pakistan)

This module provides a deep dive into Pakistan’s regulatory ecosystem for pharmaceuticals and health-related products. We’ll focus on DRAP — its structure, divisions, and role as the central regulatory authority — as well as provincial licensing boards and other authorities that interact with or support regulatory operations.

You'll learn how laws like the DRAP Act 2012 and the Drugs Act 1976 guide the functions of these bodies and how to identify which authority is responsible for various approvals, inspections, and certifications.

By the end of this module, learners will:

• Understand DRAP’s organizational structure and scope

• Identify the roles of provincial licensing boards

• Recognize how health products, OTC items, and alternative medicines are regulated

• Know the legal framework and jurisdiction of each authority

In this module, you’ll gain practical knowledge of the Common Technical Document (CTD) format as required by the Drug Regulatory Authority of Pakistan (DRAP) for pharmaceutical product registration. We’ll break down each of the five CTD modules — from administrative documents to clinical data — and explain what content is expected, how to organize your submissions, and common deficiencies to avoid.

This module focuses on the enlistment and regulation of Health, OTC, and Alternative Medicines under DRAP’s framework. You’ll get hands-on guidance on how to fill and submit official DRAP forms such as Form 1 to Form 12, and how to use checklists for firm and product enlistment—whether you’re a manufacturer or importer.

We cover documentation requirements, GMP-related forms, site verification procedures, and how to handle post-enlistment variations or shelf life extensions. You’ll also learn the distinctions between general claim products and therapeutic claim products, and how DRAP evaluates both.

Whether you're applying for new product enlistment, managing changes in your approved portfolio, or planning to operate under contract manufacturing, this module will help you comply with DRAP’s Health & OTC division standards.

In this module, you'll gain detailed, step-by-step guidance on how to use the official DRAP online portals for submitting applications, tracking approvals, and maintaining compliance. We cover each major digital service, including product registration, fee challan generation, pricing index (CPI), NOCs for import/export, clinical trial applications, and more.

You’ll also explore the key Standard Operating Procedures (SOPs) that DRAP follows while evaluating submissions, issuing certificates, and performing inspections. By the end of this module, you'll be able to confidently navigate DRAP's e-services and understand the digital workflow from application to final approval.

This is a practical, hands-on module ideal for RA officers, pharmacists, manufacturers, and consultants who want to modernize their compliance process through digital tools.