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28 - The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Cristina Sampaio  and
Swati Sathe
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

All agents approved for marketing must meet the regulatory standards of the country in which they will be marketed, and drug development programs are designed to meet these regulatory requirements.  There are frequent interactions between regulators and sponsors during the development and trial process.  The FDA in the USA, the EMA in Europe, the NMPA in China, and the Japanese PMDA and other national regulatory bodies communicate regularly and share information.  Regulators promote drug development for serious diseases with unmet needs such as Alzheimer’s disease (AD) and can use regulatory tools to facilitate the drug development process.  Regulatory agencies oversee the manufacture of treatments (drugs, monoclonal antibodies) in addition to supervising the development process through clinical trials.  Regulatory science and regulatory specifications evolve in concert with new knowledge.  Agencies now recognize mild cognitive impairment and preclinical AD as populations where therapeutic indications could apply.  Agencies have integrated biomarkers into their concepts of drug development and have specified approaches to biomarker qualification.

Keywords

Regulatory scienceDrug RegulationsFDAEMAPMDANMPABiomarkers qualificationbenefit-risk assessment
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 319 - 332
Publisher: Cambridge University Press
Print publication year: 2022

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