HCR 576: Module 7 Assignment-Compare & Contrast Regulations
HCR 576: Module 7 Assignment-Compare & Contrast Regulations
- Due Oct 7 by 11:59pm
- Points 25
- Submitting a file upload
- Available Aug 20 at 12am – Oct 8 at 11:59pm
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For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). The NDA application is the vehicle through which drug sponsors formally …
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The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
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Criteria
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Ratings
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Pts
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This criterion is linked to a Learning OutcomeRegulation table
Demonstrates understanding of health authority regulations, their differences and similarities.
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40 ptsFull MarksTable is clear, convincing and describes requirements.
0 ptsNo MarksDoes not meet criteria.
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40 pts
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This criterion is linked to a Learning OutcomeContent
Format, spelling, grammar, APA format.
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20 ptsFull MarksOrganized and clear; presents strategies, provides justification, solid reasons and data to support choice. Addresses the complexities and expectations of various health authority requirements. Demonstrates contrast between health authorities.
0 ptsNo MarksDoes not do minimal and or does not data to support leadership.
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20 pts
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This criterion is linked to a Learning OutcomeSpelling, grammar, format
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10 ptsFull MarksSpelling, grammar and formatting are complete and without errors.
0 ptsNo Marks
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10 pts
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This criterion is linked to a Learning OutcomeIndividual health authority
Specify health authority.
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30 ptsFull MarksTable is updated with all relevant information. Additional row and columns are added to highlight the differences/contrasts.
0 ptsNo Marks
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30 pts
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Introduction
The regulation of pharmaceuticals differs across global health authorities, yet each framework shares the common goal of ensuring patient safety, product quality, and therapeutic effectiveness. In the United States, the Food and Drug Administration (FDA) regulates new drug applications under Title 21 of the Code of Federal Regulations (21 CFR 211), which provides the framework for current Good Manufacturing Practices (cGMPs). In contrast, the European Medicines Agency (EMA) governs new drug applications through Annex 1 of the EU GMP guidelines, focusing on sterile medicinal products and manufacturing standards applicable across all EU member states.
This assignment compares and contrasts FDA and EU regulatory requirements to highlight areas of similarity and divergence in the approval pathway for new drugs. In addition, a third regulatory authority is included to broaden the analysis and demonstrate the complexities of global compliance. The comparison underscores not only the technical and procedural differences but also the shared principles of quality assurance and regulatory oversight.
By preparing a side-by-side table of requirements and identifying areas of alignment, this project aims to deepen understanding of international regulatory frameworks and the challenges faced by pharmaceutical companies seeking global market access. Ultimately, this analysis demonstrates the critical role of regulatory harmonization in safeguarding public health while supporting innovation in drug development.
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