10 Questions
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?
Module 1
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?
Module 4
What is the final step in bringing a drug to the marketplace?
Marketing Authorisation
Module 2 of the marketing authorisation dossier contains summaries prefaced by a brief introduction outlining the pharmacological class of the drug.
True
Which application is used in the US for approval of a new drug?
NDA
Module 1 is designed to contain region-specific information such as application forms and other administrative ________.
provisions
Match the following terms with their descriptions:
INN = Recommended International Non-proprietary Name USAN = United States Adopted Name JAN = Japanese Accepted Name BAN = British Approved Name
The quality module must contain information on the identity, characteristics, and manufacturing methods of the drug substance and final drug product.
True
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
Learn about the final step in bringing a drug to the market, including data collection and submission to regulatory agencies.
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