Barriers regulatory agencies face for approval of Parkinson's and Alzheimer's drugs in United States and Europe, and possible ways to overcome them

Master's Thesis , 2023 , 53 Pages , Grade: A

Medicine - Pharmacology, Pharmacy

There are many challenges in developing effective treatments for neurodegenerative diseases like Parkinson's and Alzheimer's. Regulatory agencies in the US and EU play a significant role in determining the efficacy and safety of drugs used to treat these conditions. However, the approval process is convoluted and frequently encounters obstacles that delay timely access to critically needed treatments. This thesis seeks to identify, examine, and suggest potential remedies for the problems regulatory bodies in both regions encounter. Through an extensive review of the literature, regulatory standards, and case studies, the thesis looks at the major challenges encountered throughout the drug approval process for Parkinson's and Alzheimer's diseases. Scientific roadblocks including the complexity of disease mechanisms and the lack of knowledge of sickness progression make it difficult to show therapy efficacy and choose the appropriate patient populations. Clinical issues arise from the diversity of the patient population, the dearth of reliable biomarkers, and the need for precise long-term data for therapy benefit assessment.

Regulatory impediments are procedures and rules that differ between the US and Europe. These include changes to regulatory structures, clinical trial designs, and data requirements. Regulatory standards must be standardised, regulatory authorities must collaborate more closely, and data requirements must be uniform to expedite the clearance process and guarantee universal access to medications.

The thesis offers various strategies that regulatory agencies, pharmaceutical companies, and researchers can use to get around these challenges. Greater stakeholder collaboration and data sharing can promote the pooling of knowledge and resources, which will lead to more thorough clinical research and better outcomes. Adaptive trial designs and master protocols are examples of cutting-edge trial designs that can aid in patient recruitment and data collection. Utilising patient registries and actual data can speed up the approval procedure and provide more information about the results of treatment. To align expectations and proactively resolve regulatory concerns, early communication between regulatory organisations and drug developers is crucial. [...]

Inhaltsverzeichnis (Table of Contents)

• CHAPTER ONE: INTRODUCTION
• 1.1. Background of study.
• 1.2. Research question
• 1.3. Parkinson disease
• 1.4. Alzheimer disease
• 1.5. Guidelines for AD and PD in Europe and United States
• 1.6. new research areas on Parkinson and Alzheimer
• CHAPTER TWO: LITERATURE REVIEW
• 2.1. PARKINSON'S DISEASE.
• 2.1.1. The symptoms of Parkinson's disease
• 2.1.2 Diagnosis of Parkinson disease
• 2.2. Alzheimer disease
• 2.2.1. The symptoms of Alzheimer's disease
• 2.2.2 diagnosis of Alzheimer disease
• 2.3. do Parkinson and Alzheimer disease treatment come under orphan drug category in Europe?
• 2.4. pharmacovigilance of Parkinson drugs and Alzheimer disease
• 2.5. Activities related to pharmacovigilance for PD and AD ·
• 2.6. role of ema for neurological disorders in Europe
• 32.6.1. Examples of Medicinal Products Approved by the EMA for Neurological Disorders
• 2.6.2. The Impact of EMA Regulation on Neurological Disorders
• 2.7. regulatory aspect for Parkinson disease in Europe
• 2.8. regulatory aspect for Alzheimer disease in Europe
• 2.9. why there is no cure for pd & ad till date
• 2.10. documents required for neurological drug approval in Europe
• 2.11. documents required for neurological drug approval in Usfda
• 2.12. how pharmacovigilance of such drugs work and what barriers regulatory agency face
• 2.13. what new treatment plans can lead to better life for Alzheimer patients
• 2.14. what new treatment plans can lead to better life for Parkinson patients
• CHAPTER THREE: METHODOLOGY
• 3.1. Research design
• 3.2. data collection
• 3.3. Ethical considerations
• 3.4. Population
• 3.5. Sampling
• 3.6. Data analysis
• 3.7. Limitations
• 3.8. Significance
• CHAPTER FOUR: RESULT AND DISCUSSION
• 4.1. issues faced by ema and usfda for approving Parkinson and Alzheimer Drugs
• 4.1.1. Issues Faced by the EMA and USFDA in Approving Drugs for Parkinson's Disease
• 4.1.2. Issues Faced by the USFDA in Approving Drugs for Alzheimer's Disease
• 4.2. how EMA and USFDA can resist the barrier they face for approving neurological diseases treatment?
• 4.3. yearly neurology drug approvals in Europe
• 4.4. yearly neurology drug refusal in europe (after clinical trials) ·
• 4.5. yearly neurology drug approvals in America
• 4.6. yearly neurology drug approvals in Rest of World
• 4.7. Possibilities for accelerated regulatory approval processes
• 4.8. comparison between ema and usfda for ad

Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)

This thesis examines the challenges faced by regulatory agencies, specifically the European Medicines Agency (EMA) and the US Food and Drug Administration (USFDA), in approving drugs for Parkinson's and Alzheimer's diseases. The research aims to identify the barriers hindering the development and approval of effective treatments for these neurological disorders. It explores the current regulatory landscape, focusing on the guidelines, approval processes, and pharmacovigilance strategies employed by these agencies. Additionally, the thesis investigates potential solutions to overcome these challenges and accelerate the approval process for new drugs.

• Regulatory Barriers to Parkinson's and Alzheimer's Drug Approval
• Pharmacovigilance and Post-Market Surveillance of Neurological Drugs
• Accelerated Approval Processes for Neurodegenerative Diseases
• Comparison of Regulatory Strategies in Europe and the United States
• Potential Solutions to Enhance Drug Development and Approval

Zusammenfassung der Kapitel (Chapter Summaries)

• CHAPTER ONE: INTRODUCTION: This chapter sets the stage for the thesis by providing a background on Parkinson's and Alzheimer's diseases, their prevalence, and the existing challenges in treating them. It outlines the research question and the scope of the study.
• CHAPTER TWO: LITERATURE REVIEW: This chapter presents a comprehensive review of existing literature related to the research topic. It discusses the symptoms, diagnosis, and treatment of Parkinson's and Alzheimer's diseases, highlighting the current limitations in available therapies. It explores the regulatory frameworks and guidelines in Europe and the United States, particularly focusing on the role of the EMA and USFDA. The chapter also delves into the challenges faced by regulatory agencies in approving neurological drugs, including pharmacovigilance concerns and the need for effective post-market surveillance.
• CHAPTER THREE: METHODOLOGY: This chapter outlines the research methodology used in the thesis, including the data collection methods, ethical considerations, and the sampling techniques employed. It also describes the data analysis approach and discusses the limitations of the study.
• CHAPTER FOUR: RESULT AND DISCUSSION: This chapter presents the findings of the research, analyzing the barriers faced by the EMA and USFDA in approving drugs for Parkinson's and Alzheimer's diseases. It identifies specific issues encountered by the agencies in the drug approval process, including the complexity of clinical trials, challenges in demonstrating efficacy, and the need for robust safety data. The chapter further discusses potential solutions to overcome these barriers and accelerate the development of new treatments.

Schlüsselwörter (Keywords)

The research focuses on the challenges encountered in the regulatory approval process for Parkinson's and Alzheimer's drugs, exploring the role of the EMA and USFDA, pharmacovigilance, accelerated approval pathways, and potential solutions to expedite drug development. Key terms and concepts include neurodegenerative diseases, regulatory barriers, clinical trials, efficacy, safety, pharmacovigilance, accelerated approval, post-market surveillance, European Medicines Agency (EMA), and US Food and Drug Administration (USFDA).

• Grade: A
• Author: Kunal Kunal (Author)
• Publication Year: 2023
• Pages: 53
• Catalog Number: V1497164
• ISBN (PDF): 9783389058671
• ISBN (Book): 9783389058688
• Language: English
• Tags: barriers, parkinson, alzheimer, united, states, europe