Global regulatory agility during covid-19 and other health emergencies

Mak, Tippi K; Lim, John C. W.; Thanaphollert, Prapassorn; Mahlangu, Gugu; Cooke, Emer

doi:10.1136/bmj.m1575

Cited by 13 publications

(17 citation statements)

References 3 publications

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“…These reviews would allow regulators to determine which specific approaches resulted in the most gains across the sector and to identify those that can be introduced temporarily during emergency situations or permanently adopted. Reviewing such approaches can also help to identify best practices that can be shared across regulatory authorities globally and allow for a closer examination to ensure that regulatory mechanisms remain fit for purpose, 53 are increasingly harmonized, and take into account the possible risks and consequences in its application.…”

Section: Embedding Regulatory Agility and Lessons Learnedmentioning

confidence: 99%

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

Bolislis¹,

Lucia²,

Dolz³

et al. 2021

Clinical Therapeutics

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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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Section: Embedding Regulatory Agility and Lessons Learnedmentioning

confidence: 99%

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

Bolislis¹,

Lucia²,

Dolz³

et al. 2021

Clinical Therapeutics

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show abstract

“…The need for regulatory agility and coordination among national regulatory authorities (NRAs) is more critical than ever to ensure that new health products can be expeditiously evaluated, while still ensuring their safety, quality and efficacy. 1 An initial approach to instituting best pandemic regulatory practices has been advocated. 2 Ongoing assessments to approve vaccines from the growing number and diversity of candidates developed at great speed adds another layer of complexity to existing regulatory hurdles such as lack of capacity and weak post marketing surveillance especially in developing countries.…”

mentioning

confidence: 99%

The COVID‐19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics

Soumyanarayanan

Choong

Leong

et al. 2021

Clinical Translational Sci

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“…There are valid arguments for “regulatory agility” during emergencies such as covid-19,5 but speed should not undermine basic standards for trustworthy evidence 6. As a 2017 report on Ebola from the US National Academy of Sciences noted, “despite [the] sense of urgency, research during an epidemic is still subject to the same core scientific and ethical requirements that govern all research on human subjects.”7 Clear evidence of the risk of bias in commercially funded research 1 should drive efforts to develop a new, but equally agile, system of independent evaluation of all tests and treatments.…”

mentioning

confidence: 99%

Commercial influence and covid-19

Moynihan

Macdonald²,

Bero

et al. 2020

BMJ

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Global regulatory agility during covid-19 and other health emergencies

Abstract: Enhanced collaboration among authorities is key to ensuring timely access to high quality health products worldwide

Cited by 13 publications

References 3 publications

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

The COVID‐19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics

Commercial influence and covid-19

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