Interview Questions on Common Technical Document (CTD) for Regulatory Affairs Freshers

1. What is the Common Technical Document (CTD)?

Answer:
CTD is a standardized format for submitting regulatory documents for drug approvals. It simplifies the submission process across multiple regions by providing a harmonized structure.

2. What are the five modules of the CTD?

Answer:
The five modules are:

1. Module 1: Administrative and Product Information (region-specific).
2. Module 2: Quality Overall Summary (QOS), Clinical and Nonclinical Overviews, and Summaries.
3. Module 3: Quality (Chemical, Pharmaceutical, and Biological Data).
4. Module 4: Nonclinical Study Reports (Pharmacology, Toxicology).
5. Module 5: Clinical Study Reports (Efficacy and Safety Data).

3. What is the purpose of the CTD format?

Answer:
The CTD format facilitates easier preparation and review of drug registration dossiers by regulatory agencies. It ensures uniformity and efficiency in drug approval processes across ICH regions.

4. Which regions follow the CTD format?

Answer:
The CTD format is used in regions regulated by ICH (USA, EU, Japan), and many other countries outside the ICH framework also accept it with minor modifications.

5. What is eCTD, and how does it differ from CTD?

Answer:
The eCTD (electronic Common Technical Document) is the digital version of CTD, allowing for electronic submissions. It streamlines document management, review, and tracking compared to the paper-based CTD.

6. What information is included in Module 1 of the CTD?

Answer:
Module 1 contains region-specific administrative information like:

• Application forms
• Product labeling (SmPC, PIL, labels)
• Patent information
• Information on orphan drug status (if applicable).

7. What are the key elements of Module 3 in the CTD?

Answer:
Module 3 includes detailed information about the drug substance and drug product, such as:

• Manufacturing process and controls
• Specifications and analytical methods
• Stability data
• Container closure systems.

8. Why is Module 2 important in the CTD?

Answer:
Module 2 provides summaries and overviews that help reviewers quickly understand the application’s key aspects without going through detailed data in Modules 3, 4, and 5.

9. What are the benefits of using the CTD format?

Answer:
Benefits include:

• Harmonization across regions.
• Simplified review process.
• Improved communication between regulatory agencies and applicants.
• Reduced duplication of efforts for multinational submissions.

10. What challenges might arise when preparing a CTD dossier?

Answer:
Challenges include:

• Ensuring completeness and accuracy of data.
• Managing region-specific requirements for Module 1.
• Coordinating input from multidisciplinary teams (clinical, nonclinical, CMC).

11. How do you ensure compliance with CTD guidelines during dossier preparation?

Answer:
Compliance is ensured by:

• Following ICH guidelines (M4 series).
• Cross-checking the dossier against regulatory requirements.
• Using templates and tools for consistency.
• Conducting thorough quality checks.

12. What role does a regulatory professional play in CTD preparation?

Answer:
Regulatory professionals:

• Coordinate the compilation of data from different teams.
• Ensure compliance with regional and ICH guidelines.
• Manage submission timelines.
• Serve as a liaison between the company and regulatory authorities.

13. How does CTD contribute to faster drug approvals?

Answer:
CTD provides a standardized format, reducing the time agencies spend understanding the dossier structure. This facilitates quicker reviews and harmonized decision-making across regions.

14. What is the significance of granularity in eCTD submissions?

Answer:
Granularity refers to dividing the dossier into smaller sections or files. It allows easier updates, navigation, and review of specific sections without revising the entire submission.

15. Can you explain the ICH guidelines related to CTD?

Answer:
The ICH M4 series covers CTD:

• M4Q: Quality information
• M4S: Safety information
• M4E: Efficacy information
  These guidelines define the structure and content for regulatory submissions.