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Pharmaceutical Quality Assurance (PHA305)
(Dr. Akram Ashames)
Assignment (1): Drug Approval and Registration Process: A Comparative Analysis
Max Grade: 20 marks
Dear Students,
This assignment on the drug approval and registration process, focusing on a selected country of
your choice. This assignment aims to enhance your understanding of regulatory procedures in
the pharmaceutical industry by comparing and contrasting the drug approval processes of your
chosen country with those of the U.S. FDA and the EU EMA. Please adhere to the following
guidelines and instructions:
Assignment Details:
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Length: The assignment should be completed within a maximum of 10 slides
(PowerPoint).
Due Date: The assignment is due on September 26, 2023, by midnight.
Submission: Please submit your assignment via Moodle, following the specified
submission guidelines.
Late Submissions:
Late submissions will be subject to grade deduction, with a penalty of [specify percentage] per
day. No submissions will be accepted after September 30, 202. It is essential to complete and
submit the assignment within the given time frame.
Academic Integrity:
Plagiarism is strictly prohibited. Ensure that all sources used are properly cited and referenced
according to the preferred citation style (e.g., APA, MLA). Use your own words and ideas to
describe the drug approval processes and compare them. Directly copying from sources or fellow
students will result in penalties.
Individual Work:
This assignment is to be completed individually. Collaboration with classmates or any form of
group work is not permitted. Each student should select a country to analyze the drug approval
and registration process, ensuring a diverse range of comparisons.
Slide structure:
1. Slide 1: Introduction
Briefly introduce the topic and the country under consideration (select one country other than USA, EU
countries, and Japan). You can choose for example: Canada, Australia, China, Russia, Turkey, South Korea,
India, etc.
State the objective of the presentation: to describe the drug approval/registration process in the selected
country and compare it with the processes of FDA (U.S.) and EMA (European Union).
2. Slide 2: Overview of Drug Approval Processes
Provide a brief overview of the drug approval processes in general.
Highlight the importance of regulatory agencies in ensuring the safety, efficacy, and quality of drugs.
3. Slide 3: Drug Approval Process in the Selected Country
Describe the regulatory authority responsible for drug approval in the selected country.
Outline the main steps involved in the drug approval process, including preclinical studies, clinical trials,
and the submission of a marketing authorization application.
Mention any specific requirements or regulations unique to the selected country.
4. Slide 4: Drug Approval Process in FDA (U.S.)
Describe the role of the U.S. Food and Drug Administration (FDA) in the drug approval process.
Explain the key stages, such as Investigational New Drug (IND) application, clinical trials, New Drug
Application (NDA) submission, and FDA review.
Discuss the FDA’s emphasis on safety, efficacy, and quality standards.
5. Slide 5: Drug Approval Process in EMA (European Union)
Explain the role of the European Medicines Agency (EMA) in the drug approval process.
Discuss the centralized procedure and mutual recognition procedure for marketing authorization in the
European Union.
Highlight the importance of scientific evaluation and harmonization of drug regulations within the EU.
6. Slide 6: Key Similarities in the Approval Processes
Identify common elements shared by the drug approval processes in the selected country, FDA, and
EMA.
Examples include preclinical testing, clinical trials, and the need for substantial evidence of safety and
efficacy.
7. Slide 7: Key Differences in the Approval Processes
Highlight significant differences between the drug approval processes in the selected country, FDA, and
EMA.
Examples may include variations in timelines, documentation requirements, or the level of detail
required in the submission dossier.
8. Slide 8: Post-Approval Monitoring and Pharmacovigilance
Discuss the importance of post-approval monitoring and pharmacovigilance in all three regulatory
systems.
Describe the systems in place to track adverse events, ensure drug safety, and enforce regulatory
compliance.
9. Slide 9: Challenges and Future Developments
Identify challenges faced by the drug approval processes in the selected country, FDA, and EMA.
Discuss potential areas for improvement and future developments, such as expedited approval
pathways or the use of real-world evidence.
10. Slide 10: Conclusion and References
Summarize the main points discussed throughout the presentation.
Provide a list of references used in the research and preparation of the presentation.
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