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Pharmaceutical Regulatory Affairs: Drug Approval

Name: Pharmaceutical Regulatory Affairs: Drug Approval
Rating: 4.7 (14 reviews)

Pharma Course, NDA, ANDA, CTD, DMF, USFDA, EMA, ICH Guidelines, GMP, Clinical Research, Orange Book, Regulatory Affairs

Created byGuided Academy

Last updated 8/2026

English

English [Auto],

What you'll learn

Acquire foundational knowledge of Drug Regulatory Affairs (DRA), including its core concepts and terminology.
Need for Regulatory Affairs (RA) Professionals in the Pharmaceutical Industry and the Essential Qualities of an RA Professional
Understand the role of RA professionals in the pharmaceutical industry, identify employers, and explain the objectives of Drug Regulatory Affairs (DRA)
Understand the historical evolution of U.S. drug laws and regulations, the U.S. FDA regulatory framework governing pharmaceutical research & development (R&D)
Understand major drug regulatory agencies in the U.S. and other countries, and access official websites and regulatory guidance PDFs
Understand the U.S. drug approval process, including preclinical studies, IND, NDA, ANDA, the Hatch–Waxman Act, and key regulatory requirements
Understand the U.S. FDA Orange Book and the Therapeutic Equivalence Evaluation Codes used for approved drug products
Understand Drug Master Files (DMFs), including types, benefits, requirements, submission, annual updates, database status, and key regulations
Understand the Common Technical Document (CTD), its modules, and differences between the ASEAN CTD (ACTD) and ICH-CTD
Understand the Electronic Common Technical Document (eCTD), its components, submission process, paper CTD vs. eCTD, eCTD software, and lifecycle management
Understand GMP and cGMP principles, regulatory requirements, quality systems, documentation, compliance, audits, validation in pharma
Understand the Biologics License Application (BLA) process, the U.S. FDA Purple Book, including its role in the approval and regulation of biological products
Develop the ability to navigate key regulatory websites, including the ICH Guidelines, to locate and interpret relevant regulatory information
Build a strong foundation for a successful Regulatory Affairs (RA) career through understanding Drug Regulatory Affairs (DRA), compliance, regulatory concepts
Understand the principles, processes, regulatory requirements of Clinical Research

Course content

11 sections • 37 lectures • 2h 1m total length

Introduction to Regulatory Affairs4:12
Understanding Key Terms in Drug Regulatory Affairs4:49
Learn key terms in drug regulatory affairs, including regulation, drug regulation, pharmaceutical regulation, regulatory body, and regulatory authority, plus essential concepts like INDA, NDA, ANDA, MAA, DMF, and ASMF.
Why Regulatory Affairs is Important0:58
Types of Companies That Hire Regulatory Affairs Professionals1:46
Objectives of Regulatory Affairs2:31
Explore how regulatory affairs supports research, production, and quality control, manages global submissions, tracks law changes, and shapes strategy to ensure compliant, efficient product approvals.
Qualities of a Good Regulatory Affairs Professional3:43
Develop leadership, analytical, and negotiation skills to navigate evolving regulatory updates and laws, while mastering presentation, crisis management, IT literacy, and time management for GMP, pharmacovigilance, and faster market access.

Drug Approval Process and Clinical Trials (FDA)3:36
Follow the FDA drug approval path from discovery through preclinical testing, IND submission, and phase 1 to phase 3 clinical trials to NDA review, labeling, GMP inspections, and post-marketing surveillance.
New Drug Development – Preclinical Steps2:12
Explore the preclinical stage of new drug development, including computer simulations, lab and animal studies, prototype testing, multiple related compounds, safety assessments, GLP compliance, and groundwork for clinical trial design.
Investigational New Drug Application (IND)4:00
Explore how the investigational new drug application to the FDA authorizes human trials. Understand when an INDA is required, the IRB role, and how a clinical hold safeguards participants.
New Drug Application (NDA) Process3:20
Navigate the new drug application (NDA) process, including CTD submission to the FDA's CDER, required sections, and steps from filing to potential approval or deficiencies.

ANDA Part 13:30
ANDA Part 23:47
ANDA Part 33:37
Exploring the ANDA process for generic drugs, this lecture details pharmaceutical equivalence, bioequivalence, and therapeutic equivalence criteria, and outlines CTD filing, FDA review, and pre-approval inspections.
Categories of Generic Products2:17
Explore the categories of generic products, including ordinary generics, value-added generics, new delivery systems, biogenerics, branded generics, and patent-expired molecules, plus three entry pathways: line extensions, retargeting, and new products.

Introduction to Good Manufacturing Practices3:18
Explore how GMP safeguards quality, safety, and efficacy in pharmaceutical production by establishing a quality assurance framework with controlled conditions to prevent contamination, mislabeling, and incorrect ingredient levels.
Difference Between GMP and cGMP3:06
Compare GMP and CGMP to understand their scope, cost, and application in pharmaceutical quality assurance. See that CGMP is current, technology-driven, and entails higher quality assurance and stricter process controls.
Core Principles of GMP Compliance3:40
Learn the core principles of GMP compliance, including minimum standards, procedures, validation, contamination control, and designing quality into pharmaceutical manufacturing processes.

Requirements

Strong desire in understanding the concept of Dug Regulatory Affairs, curiosity in understanding the Drug Development Process
Basic understanding of Pharmacy/ Medical Science, Life Science, or Healthcare is helpful but not mandatory
Suitable for beginners, students, and working professionals
Basic level of English, Good quality Internet connection, Desktop/ Laptop/ Smartphone required (Since you are learning Online)

Description

Regulatory Affairs is one of the most important functions in the pharmaceutical and biotechnology industries. It ensures that drugs are developed, manufactured, and marketed in compliance with regulatory guidelines and global health authorities.

This comprehensive course is designed to provide a strong foundation in Pharmaceutical Regulatory Affairs, covering the complete regulatory lifecycle of drug development and approval.

In this course, you will learn the key concepts, regulatory frameworks, and submission processes used by regulatory agencies such as the FDA. The course explains the entire journey of a pharmaceutical product—from early development stages to regulatory approval and post-marketing compliance.

We begin with the fundamentals of regulatory affairs, including important terminology, objectives, and the role of regulatory professionals in pharmaceutical companies. You will then explore the drug development process, including preclinical research, clinical trials, and regulatory submissions such as IND, NDA, and ANDA.

The course also explains critical regulatory documentation including Drug Master Files (DMF) and the Common Technical Document (CTD) format used globally for regulatory submissions. You will gain a clear understanding of electronic submissions (eCTD) and the differences between various regulatory pathways.

In addition, the course covers important compliance topics such as Good Manufacturing Practices (GMP) and regulatory strategy used to successfully bring pharmaceutical products to market.

By the end of this course, you will have a clear understanding of how regulatory affairs works in the pharmaceutical industry and how drugs are approved by regulatory authorities.

This course is ideal for students, pharmacy graduates, life science professionals, and anyone interested in building a career in regulatory affairs.

What You Will Learn

Basic Understanding and Terminologies related to DRA, DRA objectives
Role and Responsibilities of Regulatory Affairs Professionals
USFDA regulatory requirements and Drug Approval Procedure
Drug Regulatory Submissions: Investigational New Drug Application (INDA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA)
Orange Book
Purple Book
Drug Master File (DMF)
Common Technical Document (CTD), Electronic Common Technical Document (eCTD)
Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP)
Many more...

Eligibility Requirements

Education and experience:

A minimum of a baccalaureate or equivalent Lifescience subjects OR
Bachelors of Pharmacy, Masters of Pharmacy, Ph.D In Pharmacy, Industrial Professional
A master’s degree of regulatory or regulatory-related experience; OR
A doctorate degree (e.g., medical, dental degree, PharmD, PhD, ScD, JD) and at least one year regulatory or regulatory-related experience
No Prerequisite required only need Curiosity over new learnings

Who this course is for:

Pharmacy students (B.Pharm, M.Pharm, Pharm.D)
Fresh graduates seeking a career in pharmaceutical regulatory affairs
Life sciences, biotechnology, and healthcare students
Ph.D Students and professionals
Professionals working in pharma, quality, production, or R&D looking to transition into regulatory roles

Pharmaceutical Regulatory Affairs: Drug Approval

What you'll learn

Explore related topics

Course content

Introduction to Regulatory Affairs6 lectures • 18min

History and Roles in Regulatory Affairs2 lectures • 6min

Drug Development and Approval Process4 lectures • 13min

Generic Drug Approval (ANDA)4 lectures • 13min

Drug Classification and Regulatory Databases5 lectures • 15min

Drug Master Files (DMF)4 lectures • 11min

Common Technical Document (CTD & eCTD)4 lectures • 14min

Regulatory Strategy2 lectures • 11min

GMP and Compliance3 lectures • 10min

Clinical Research and Biologics2 lectures • 9min

Requirements

Description

Who this course is for: