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Future directions in regulatory affairs.

Orin Chisholm¹, Helen Critchley²

¹Faculty of Medicine and Health, Sydney Pharmacy School, The University of Sydney, Sydney, NSW, Australia.

Frontiers in Medicine

|January 26, 2023

Summary

Regulatory affairs professionals must adapt to evolving global trends impacting therapeutic product development. This includes navigating scientific, digital, and patient-centric shifts, alongside geopolitical and environmental considerations.

Keywords:

digital disruption drug development future trends regulatory affairs regulatory science skills

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Area of Science:

Regulatory Affairs
Pharmaceutical Development
Health Policy

Background:

The regulatory affairs landscape is influenced by global megatrends, including geopolitical shifts and the green economy.
Advances in science, digital disruption, and a patient-centric focus are reshaping therapeutic product development.
The COVID-19 pandemic accelerated changes in scientific collaboration and regulatory authority interactions.

Purpose of the Study:

To discuss current trends impacting the development of new therapies.
To analyze how these trends affect the role of regulatory affairs professionals.
To provide insights for regulatory professionals to navigate future challenges.

Main Methods:

Literature review of global trends affecting therapeutic product development.
Analysis of the impact of these trends on regulatory affairs.
Discussion of challenges and strategies for regulatory professionals.

Main Results:

Global megatrends necessitate a focus on manufacturing, supply chain security, and environmental impact.
Scientific and digital advancements, patient centricity, and inter-regulatory collaboration are key drivers of change.
Regulatory affairs professionals face evolving demands requiring adaptability and foresight.

Conclusions:

The role of regulatory affairs professionals is expanding beyond traditional compliance.
Adaptation to emerging trends is crucial for ensuring timely access to innovative therapies.
Proactive engagement with scientific, digital, and patient-focused advancements is essential for regulatory success.