COVID‐19: A Catalyst to Accelerate Global Regulatory Transformation

Stewart, J C; Honig, Peter K.; Aljuburi, Lina; Autor, Deborah; Berger, Susan; Brady, Patrick; Fitton, Helen; Garner, Carlos; Garvin, Michael R.; Hukkelhoven, Mathias; Kowalski, Robert; Milligan, Sandra; O'Dowd, L.; Reilly, Edward L.; Roberts, Khyati; Robertson, Alan; Taisey, Mark; Thakkar, Roopal; Baelen, Karin Van; Wegner, Max

doi:10.1002/cpt.2046

Cited by 20 publications

(17 citation statements)

References 5 publications

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“…To address the effects of COVID-19 and to simultaneously ensure the continuity of development of non-COVID treatments, regulators have demonstrated significant regulatory agility while maintaining high standards of quality, tolerability, and effectiveness. 1 Regulators have adopted and made public crucial steps to raise awareness and to provide guidance to stakeholders on how to respond and navigate the current pandemic. In doing so, they have demonstrated tremendous agility.…”

Section: Introductionmentioning

confidence: 99%

“…In this paper, we present several documents or informational materials related to the regulatory environment around the development and management of medical products concerning the COVID-19 pandemic. Some of these documents refer to actions, initiatives, or exceptional approaches where health or regulatory authorities have either: (1) advanced existing initiatives aimed at agile and responsive regulatory systems and processes; or (2) introduced new and innovative ways to expedite and improve such processes. For the purpose of this review, we refer to regulatory agility as the willingness of authorities to take quick action within the accepted regulatory framework to ensure that the regulatory ecosystem swiftly responds to the challenges imposed by the pandemic for the ultimate benefit of patients and society as a whole.…”

Section: Introductionmentioning

confidence: 99%

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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: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

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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“…Other authors have argued for applying “regulatory flexibility” beyond the current COVID‐19 pandemic and against a return to previous practices, for the benefit of patients suffering from (life‐threatening) diseases 33,40–42 . This study has shown that regulators have readily accepted telemedicine visits, enhanced remote CT monitoring, DtP IMP supply, and simplified interaction with the authorities via digital means during the pandemic, albeit temporarily.…”

Section: Discussionmentioning

confidence: 84%

“…Other authors have argued for applying "regulatory flexibility" beyond the current COVID-19 pandemic and against a return to previous practices, for the benefit of patients suffering from (life-threatening) diseases. 33,[40][41][42] This study has shown that regulators have readily accepted telemedicine visits, enhanced remote CT monitoring, DtP IMP supply, and simplified interaction with the authorities via digital means during the pandemic, albeit temporarily. However, country-specific differences in the guidance provided within the European Union (mainly regarding regulatory management, DtP IMP supply from the sponsor, and rSDV; Table S3) could have made it difficult for sponsors to adapt to these guidances for trials conducted in multiple MSs.…”

Section: Implications Of This Studymentioning

confidence: 79%

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union

Jong

Santa‐Ana‐Téllez

Thiel

et al. 2021

Clin Pharma and Therapeutics

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The COVID-19 pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and guidance related to COVID-19 in the European Union (EU). The European Medicines Agency (EMA) and national competent authorities' (NCAs) websites were searched in September and October 2020 for guidances on the management of CTs during the pandemic published from January 2020 onward. "Regulatory readiness" was defined as the number of days from the first European COVID-19 case (January 24, 2020) to the first published guidance by the respective NCA. "Regulatory guidance" was evaluated by coding the guidances for the following predefined operational trial activities important for ongoing CTs: obtaining informed consent, participant information, clinic visits, home health visits, telemedicine visits, self-monitoring, investigational medicinal product (IMP) supply, IMP adherence monitoring, CT monitoring, documentation management, regulatory management, and safety management. Twenty-four of the 27 EU NCAs published country-specific guidance. The time from the first European COVID-19 case to the first published EMA guidance was 56 days and ranged from 47 to 66 days for the first national guidances. Guidance was provided most frequently for regulatory management (24/24), safety management (23/24), documentation management (22/24), and CT monitoring (22/24). The regulatory guidance provided during the pandemic, ensuring participant safety and data integrity, may now be the starting point to innovate future CT conduct.

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“…New systems could accommodate new forms of evidence from non-traditional sources such as real-world evidence (eg, patient electronic health records and patient experience data) and apply tools such as machine-based learning and artificial intelligence. 16 Although this is a long-term journey and initially will be pioneered by more well-resourced regulators, the hope is that such a system can be designed to be scalable for use by all regulators and so the anticipated benefits of streamlined processes, reduced redundancy and rework, and enriched regulatory decision making will ultimately benefit all patients globally.…”

Section: Digital As a New Regulatory Mainstaymentioning

confidence: 99%

Strengthening regulatory systems for medicines in a changed world: where do we go from here?

2021

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COVID‐19: A Catalyst to Accelerate Global Regulatory Transformation

Cited by 20 publications

References 5 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

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union

Strengthening regulatory systems for medicines in a changed world: where do we go from here?

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