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Pro

Fellow

About Pricing Donate

Sign inJoin Free

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FreeGCP delivers ICH E6(R3)-aligned modules, scenario-based assessments, and verifiable credentials shaped with practicing CRAs and compliance leads.

FreeGCP is an independent training provider and is not affiliated with or endorsed by ICH, FDA, EMA, MHRA, or any regulatory authority. Our courses are educational and aligned with ICH E6(R3), and acceptance of training certificates depends on each organization's policies.

Global accessICH E6(R3)Independent & free

Training

GCP Certification
All Courses
GCP Training
Free Certification
Requirements
Renewal

Topics

RBQM Training
Quality by Design
CtQ Factors
Risk-Based Monitoring
ICH vs FDA E6(R3)

Services

All Services
Training Solutions
Compliance Audits
Strategic Consulting

Resources

Research Tools
All Resources
GCP Essentials
Documents
Glossary

Company

About Us
Contact Us
Pricing
GCP Fellowship

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© 2026 FreeGCP. All rights reserved.

Designed in California, USA 🇺🇸 🏝️

Privacy Policy·Terms of Service·Cookie Policy

Good Clinical Practice (GCP)Course 1 of 2

Enroll free →

Course Preview

Discovery and Preclinical Research

The IND and Clinical Development

Regulatory Review and Approval

Beyond Approval: Post-Marketing

Good Clinical Practice (GCP)1 of 2

Free Lesson Preview

Regulatory Review and Approval

Regulatory Review and Approval

Learn how drugs move from completed trials to market authorization

Good Clinical Practice (GCP)

Full course · Clinical Research Foundations

Start your GCP certificate

Good Clinical Practice (GCP)Course 1 of 2

Enroll free →

Course Preview

Discovery and Preclinical Research

The IND and Clinical Development

Regulatory Review and Approval

Beyond Approval: Post-Marketing

Good Clinical Practice (GCP)1 of 2

Free Lesson Preview

Regulatory Review and Approval

Regulatory Review and Approval

Learn how drugs move from completed trials to market authorization

Good Clinical Practice (GCP)

Full course · Clinical Research Foundations

Start your GCP certificate

What you will learn

By the end of this lesson, you will be able to:

1
Explain what an NDA and BLA are and what they contain
2
Describe the major components of a regulatory submission
3
Compare the different FDA expedited approval pathways
4
Outline the FDA review process from submission to decision
5
Explain what happens when the FDA issues a Complete Response Letter
6
Describe post-approval commitments and ongoing requirements
7
Recognize how the EMA centralized procedure compares to FDA approval

The evidence pillars supporting a market authorization request

You're already ahead of most

This lesson is part of a complete GCP certification track — 2 courses, quizzes, a final exam, and a certificate recognized by 18+ trial sponsors. It's entirely free.

Start your GCP certificate

Already enrolled? Sign in

What you will learn

By the end of this lesson, you will be able to:

1
Explain what an NDA and BLA are and what they contain
2
Describe the major components of a regulatory submission
3
Compare the different FDA expedited approval pathways
4
Outline the FDA review process from submission to decision
5
Explain what happens when the FDA issues a Complete Response Letter
6
Describe post-approval commitments and ongoing requirements
7
Recognize how the EMA centralized procedure compares to FDA approval

The evidence pillars supporting a market authorization request

You're already ahead of most

This lesson is part of a complete GCP certification track — 2 courses, quizzes, a final exam, and a certificate recognized by 18+ trial sponsors. It's entirely free.

Start your GCP certificate

Already enrolled? Sign in