Regulatory Agilities in the Time of COVID-19: Overview, Trends, and
Opportunities
#MMPMID33353762
Bolislis WR
; de Lucia ML
; Dolz F
; Mo R
; Nagaoka M
; Rodriguez H
; Woon ML
; Yu W
; Kühler TC
Clin Ther
2021[Jan]; 43
(1
): 124-139
PMID33353762
show ga
PURPOSE: Crucial steps have been adopted by health and regulatory authorities
around the world to respond to the COVID-19 pandemic. This review aims to
highlight these steps by providing an overview of the regulatory approaches
adopted during the onset of the pandemic, provide an assessment of observed
trends, and offer some reflections and proposals to leverage learnings and
opportunities from this current pandemic. METHODS: Documents and informational
materials on regulating the development and management of medical products during
the COVID-19 pandemic were collected and classified. These materials were sourced
from official websites and press releases from health authorities and
international bodies from selected markets across the globe, and covered the
period between January and July 2020. Additional information to support this
study was gathered through a literature review and analysis of related data
available from the public domain, and was complemented with the authors' personal
experience. FINDINGS: Communication has been vital in addressing the impact of
COVID-19. A total of 1705 documents and informational materials related to health
or regulatory response to the COVID-19 pandemic were gathered. Of these, 343
(around 20%) were identified as regulatory agilities. These agile approaches were
classified into 3 categories, namely, where health and regulatory authorities
had: (1) facilitated product management across the entire lifecycle, notably in
expediting medical product use for COVID-19, ensuring the continuity of clinical
trials, and addressing supply chain issues; (2) strengthened international
cooperation; and (3) addressed regulatory burden with the adoption of electronic
and digital tools. IMPLICATIONS: While many regulatory measures have been
introduced temporarily as a response to the COVID-19 crisis, there are
opportunities for leveraging an understanding from these approaches in order to
collectively achieve more efficient regulatory systems and to mitigate and
address the impact of COVID-19 and further future-proof the regulatory
environment.
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