Podcast
Questions and Answers
What is the final step in bringing a drug to the marketplace?
What is the final step in bringing a drug to the marketplace?
Marketing authorisation
Which module in the marketing authorisation dossier typically contains region-specific information?
Which module in the marketing authorisation dossier typically contains region-specific information?
Module 3 of the marketing authorisation dossier focuses on the ______ of the drug substance and final drug product.
Module 3 of the marketing authorisation dossier focuses on the ______ of the drug substance and final drug product.
quality
Which module contains reports of all the non-clinical studies conducted to investigate the properties of the drug substance/product?
Which module contains reports of all the non-clinical studies conducted to investigate the properties of the drug substance/product?
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What is the final step in bringing a drug to the marketplace?
What is the final step in bringing a drug to the marketplace?
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Module 2 of the marketing authorisation dossier contains summaries prefaced by a brief introduction outlining the pharmacological class of the drug.
Module 2 of the marketing authorisation dossier contains summaries prefaced by a brief introduction outlining the pharmacological class of the drug.
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Which application is used in the US for approval of a new drug?
Which application is used in the US for approval of a new drug?
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Module 1 is designed to contain region-specific information such as application forms and other administrative ________.
Module 1 is designed to contain region-specific information such as application forms and other administrative ________.
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Match the following terms with their descriptions:
Match the following terms with their descriptions:
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The quality module must contain information on the identity, characteristics, and manufacturing methods of the drug substance and final drug product.
The quality module must contain information on the identity, characteristics, and manufacturing methods of the drug substance and final drug product.
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Study Notes
Marketing Authorisation
- Final step in bringing a drug to the marketplace
- Involves submitting a comprehensive dossier to the regulatory authority
- In the EU, it's called Market Authorisation, while in the US, it's called New Drug Application (NDA)
Types of Applications
- INDA (Investigational New Drug Application): for originator drugs
- ANDA (Abbreviated New Drug Application): for generic drugs
The Dossier
- Organised into 5 modules
- Module 1 is region-specific and contains administrative provisions
- Module 1 is not harmonised and is not considered part of the CTD (Common Technical Document) structure
Module 3: Quality
- Contains information on the identity, characteristics, manufacturing methods, control, packaging, and stability of both the drug substance and final drug product
- Identity: includes recommended International Non-proprietary Name (INN), other non-proprietary names, chemical name, and CAS registry number
- Characterisation: includes physical and chemical characteristics of the drug substance
- Manufacturing process: includes descriptions of manufacturing steps, process flow diagrams, and discussions of critical scale-up steps and process development history
- Control: includes control points, specifications, test methods, reference standards, and methods validation data
- Packaging: includes information on closure/packaging systems, material specifications, suitability/compatibility with the pharmaceutical product, and dimensional specifications
- Stability: includes stability protocols and data, along with commitment and protocols to continue stability testing post-approval
Module 4: Non-Clinical Study Reports
- Contains data from non-clinical studies investigating pharmacological and toxicological properties of the drug substance/product
Module 5: Clinical Study Reports
- Contains reports of clinical studies and related data demonstrating safety and efficacy of the drug in human subjects
Module 2: Summaries
- Includes an introduction outlining the pharmacological class, mode of action, and proposed clinical use of the drug
- Overview reports introduce the reviewer to the case for authorisation of the drug for proposed indications for use
- Written by experts who draw on data from across different studies to substantiate particular points in terms of efficacy, safety, or quality
Marketing Authorisation
- Final step in bringing a drug to the marketplace
- Involves submitting a comprehensive dossier to the regulatory authority
- In the EU, it's called Market Authorisation, while in the US, it's called New Drug Application (NDA)
Types of Applications
- INDA (Investigational New Drug Application): for originator drugs
- ANDA (Abbreviated New Drug Application): for generic drugs
The Dossier
- Organised into 5 modules
- Module 1 is region-specific and contains administrative provisions
- Module 1 is not harmonised and is not considered part of the CTD (Common Technical Document) structure
Module 3: Quality
- Contains information on the identity, characteristics, manufacturing methods, control, packaging, and stability of both the drug substance and final drug product
- Identity: includes recommended International Non-proprietary Name (INN), other non-proprietary names, chemical name, and CAS registry number
- Characterisation: includes physical and chemical characteristics of the drug substance
- Manufacturing process: includes descriptions of manufacturing steps, process flow diagrams, and discussions of critical scale-up steps and process development history
- Control: includes control points, specifications, test methods, reference standards, and methods validation data
- Packaging: includes information on closure/packaging systems, material specifications, suitability/compatibility with the pharmaceutical product, and dimensional specifications
- Stability: includes stability protocols and data, along with commitment and protocols to continue stability testing post-approval
Module 4: Non-Clinical Study Reports
- Contains data from non-clinical studies investigating pharmacological and toxicological properties of the drug substance/product
Module 5: Clinical Study Reports
- Contains reports of clinical studies and related data demonstrating safety and efficacy of the drug in human subjects
Module 2: Summaries
- Includes an introduction outlining the pharmacological class, mode of action, and proposed clinical use of the drug
- Overview reports introduce the reviewer to the case for authorisation of the drug for proposed indications for use
- Written by experts who draw on data from across different studies to substantiate particular points in terms of efficacy, safety, or quality
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Description
Learn about the final step in bringing a drug to the market, including data collection and submission to regulatory agencies.
