Highlights
- •Rolling Reviews were offered as a regulatory agility during the COVID-19 pandemic
- •Rolling Reviews are resource intensive but faster than standard procedures
- •Rolling Reviews allowed COVID-19 vaccines to be approved in record times
- •Rolling Reviews are amenable to being applied beyond health emergencies
Abstract
Purpose
Methods
Findings
Implications
Key words
Introduction
WHO, Timeline: WHO's COVID-19 response https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline#event-0 Last accessed 29 October 2021
WHO, Timeline: WHO's COVID-19 response https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline#event-0 Last accessed 29 October 2021
Domenico Cucinotta, Maurizio Vanelli, WHO Declares COVID-19 a Pandemic, https://pubmed.ncbi.nlm.nih.gov/32191675/ Last accessed 29 October 2021
Winona Rei Bolislis Maria Lucia de Lucia, Felipe Dolz Runyi Mo Makoto Nagaoka Heraclio Rodriguez May Li Woon Wei Yu Thomas C. Kühler, Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities https://www.sciencedirect.com/science/article/pii/S0149291820305257 Last accessed 29 October 2021
WHO and ICMRA joint Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during Covid-19 pandemic –December 2020 https://www.icmra.info/drupal/sites/default/files/2021-12/Regulatory_Flexibilities_during_COVID-19_Report.pdf Last accessed 2 December 2021
Winona Rei Bolislis Maria Lucia de Lucia, Felipe Dolz Runyi Mo Makoto Nagaoka Heraclio Rodriguez May Li Woon Wei Yu Thomas C. Kühler, Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities https://www.sciencedirect.com/science/article/pii/S0149291820305257 Last accessed 29 October 2021
Bruno Speder:“ Rolling Reviews – a useful tool to speed up the regulatory review process” https://hvivo.com/wp-content/uploads/2021/04/Speder-Bruno-Rolling-Reviews-Feature-May-2021.pdf Last accessed 26 November 2021
FDA, Fast Track, https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track Last accessed 29 October 2021
EMA, Pandemic report and lessons learned Outcome of the European Medicines Agency's activities during the 2009 (H1N1) flu pandemic, https://www.ema.europa.eu/en/documents/report/pandemic-report-lessons-learned-outcome-european-medicines-agencys-activities-during-2009-h1n1-flu_en.pdf Last accessed 29 October 2021
EMA, EMA plan for emerging health threats, https://www.ema.europa.eu/en/documents/other/ema-plan-emerging-health-threats_en.pdf Last accessed 29 October 2021
EMA, EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines, https://www.ema.europa.eu/en/documents/other/ema-initiatives-acceleration-development-support-evaluation-procedures-covid-19-treatments-vaccines_en.pdf Last accessed 29 October 2021
Methods
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry, https://www.fda.gov/media/142749/download Last accessed 29 October 2021
UK MHRA, Guidance Rolling review for marketing authorisation applications, https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications Last accessed 29 October 2021
Swissmedic, Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic HMV4, https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_044d_wl_zulassungsverfahren_covid-19.pdf.download.pdf/ZL000_00_044d_WL_Zulassungsverfahren_f%C3%BCr_Covid_19_Arzneimittel_im_Pandemiefall.pdf Last accessed 26 October 2021
Health Canada, Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements, https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines/rolling-submissions-non-clinical-requirements.html Last accessed 26 October 2021
Results
FDA, Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry, https://www.fda.gov/media/142749/download Last accessed 29 October 2021
UK MHRA, Guidance Rolling review for marketing authorisation applications, https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications Last accessed 29 October 2021
Swissmedic, Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic HMV4, https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_044d_wl_zulassungsverfahren_covid-19.pdf.download.pdf/ZL000_00_044d_WL_Zulassungsverfahren_f%C3%BCr_Covid_19_Arzneimittel_im_Pandemiefall.pdf Last accessed 26 October 2021
EMA, EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines, https://www.ema.europa.eu/en/documents/other/ema-initiatives-acceleration-development-support-evaluation-procedures-covid-19-treatments-vaccines_en.pdf Last accessed 26 October 2021
EMA, EMA considerations on COVID-19 vaccine approval, https://www.ema.europa.eu/en/documents/other/ema-considerations-covid-19-vaccine-approval_en.pdf Last accessed 26 October 2021
Health Canada, Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements, https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines/rolling-submissions-non-clinical-requirements.html Last accessed 26 October 2021
HSA, Pandemic Special Access Route Facilitates Singapore's access to critical novel vaccines, medicines and medical devices, https://www.hsa.gov.sg/hsa-psar Last accessed 26 October 2021
HSA, guidance note on psar for supply of emergency therapeutic products february 2021, https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/annex-a-to-guidance-note-on-psar-for-emergency-tp_feb2021_final.pdf Last accessed 26 October 2021

EMA, COVID-19 vaccines: development, evaluation, approval and monitoring, https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring Last accessed 26 October 2021
EMA, COVID-19 vaccines: development, evaluation, approval and monitoring, https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring Last accessed 26 October 2021
EMA, COVID-19 guidance: evaluation and marketing authorization https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/guidance-developers-companies/covid-19-guidance-evaluation-marketing-authorisation Last accessed 25 November 2021
Winona Rei Bolislis Maria Lucia de Lucia, Felipe Dolz Runyi Mo Makoto Nagaoka Heraclio Rodriguez May Li Woon Wei Yu Thomas C. Kühler, Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities https://www.sciencedirect.com/science/article/pii/S0149291820305257 Last accessed 29 October 2021
EMA, COVID-19 vaccines: development, evaluation, approval and monitoring, https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-development-evaluation-approval-monitoring Last accessed 26 October 2021
Pharmaintelligence, EMA's Emer Cooke on the Future of Rolling Reviews & the End of Remote Meetings, https://pink.pharmaintelligence.informa.com/PS144983/EMAs-Emer-Cooke-On-The-Future-Of-Rolling-Reviews–The-End-Of-Remote-Meetings Last accessed 30 November 2021
European Medicine Agency, Comirnaty European Public assessment report, https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty Last accessed 26 October 2021
European Medicine Agency, Vaxzevria European Public Assessment report, https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca Last accessed 26 October 2021
European medicine agency, Spikevax European Public assessment report, https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax-previously-covid-19-vaccine-moderna Last accessed 26 October 2021
European Medicine Agency, Janssen covid-19 vaccine european public assessment report, https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf Last accessed 26 October 2021
EMA, Questions and Answers: Conditional Marketing Authorisation of COVID-19 Vaccines in the EU l What is the EU doing to accelerate the authorisation process for the COVID-19 vaccines? https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390 Last accessed 26 October 2021
EMA, “Announcement of withdrawal of CureVac, https://www.ema.europa.eu/en/news/ema-ends-rolling-review-cvncov-covid-19-vaccine-following-withdrawal-curevac-ag Last accessed 30 November 2021


EMA, “Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021” https://www.ema.europa.eu/en/events/extraordinary-meeting-pharmacovigilance-risk-assessment-committee-prac-20-april-2021 Last accessed 30 November 2021
EMA, “Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 29 December 2020” https://www.ema.europa.eu/en/events/extraordinary-meeting-committee-medicinal-products-human-use-chmp-29-december-2020 Last accessed 30 November 2021
EMA, “Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 25 November 2021” https://www.ema.europa.eu/en/events/extraordinary-meeting-committee-medicinal-products-human-use-chmp-25-november-2021 Last accessed 30 November 2021
Sponsor | RR Cycle 1 (Submission Date and Data Package Content) | RR Cycle 2 (Submission Date and Data Package Content) | RR Cycle 3 (Submission Date and Data Package Content) | CMA | No. of Extraordinary Meetings |
---|---|---|---|---|---|
AstraZeneca | 10/1/2020 Nonclinical | 12/12/2020 Nonclinical Quality | 12/242020 | 1/122021 | 2 |
Pfizer | 10/6/2020 Nonclinical | 11/7/2020 Quality | 12/12020 | 5 | |
Moderna | 11/16/2020 Nonclinical | 12/1/2020 | 2 | ||
Janssen | 12/1/2020 Nonclinical Clinical | 1/25/2021 Nonclinical | 2/16/2021 | 1 |
EMA, “EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG” https://www.ema.europa.eu/en/news/ema-ends-rolling-review-cvncov-covid-19-vaccine-following-withdrawal-curevac-ag Last accessed 26 November 2021
EMA, “EMA receives application for conditional marketing authorisation of Novavax's COVID-19 vaccine, Nuvaxovid” https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid Last accessed 26 November 2021
EMA, “COVID-19: EMA recommends authorisation of two monoclonal antibody medicines”, https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines Last accessed 26 November 2021
EMA, “COVID treatments” https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-treatments Last accessed 26 November 2021
EMA, “Assessment report, Veklury” https://www.ema.europa.eu/en/documents/assessment-report/veklury-epar-public-assessment-report_en.pdf Last accessed 2 November 2021
FDA, “Frequently Asked Questions for Velklury (remdesivir)”https://www.fda.gov/media/137574/download. Last accessed 2 November 2021

EMA, “EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly” https://www.ema.europa.eu/en/news/ema-ends-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19-following-withdrawal-lilly. Last accessed 22 December 2021
Discussion
EMA, HMA/EMA statement on approval of vaccines, https://www.ema.europa.eu/en/news/hmaema-statement-approval-vaccines Last accessed 26 October 2021
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EMA, COVID-19 EMA pandemic Task Force, https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/emas-governance-during-covid-19-pandemic#covid-19-ema-pandemic-task-force-section Last accessed 26 October 2021
EMA, “Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)” https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-covid-19-ema-pandemic-task-force-covid-etf_en.pdf Last accessed 25 November 2021
European Commission, Questions and Answers: Conditional Marketing Authorisation of COVID-19 Vaccines in the EU https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390 Last accessed 25 November 2021
White paper Every Day Counts on Oncology treatments https://www.vintura.com/wp-content/uploads/2020/08/White-paper-every-day-counts-improving-time-to-patient-access-to-innovative-oncology-therapies-in-europe_from-EFPIA_and_Vintura.pdf Last accessed 11 December 2021
Mckinsey & company, Fast-forward: Will the speed of COVID-19 vaccine development reset industry norms?, https://www.mckinsey.com/industries/life-sciences/our-insights/fast-forward-will-the-speed-of-covid-19-vaccine-development-reset-industry-norms Last accessed 25 November 2021
Mckinsey & company, Fast-forward: Will the speed of COVID-19 vaccine development reset industry norms?, https://www.mckinsey.com/industries/life-sciences/our-insights/fast-forward-will-the-speed-of-covid-19-vaccine-development-reset-industry-norms Last accessed 25 November 2021
FDA, “Frequently Asked Questions: Breakthrough Therapies” https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies Last accessed 26 October 2021
FDA, “Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review” https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review Last accessed 26 October 2021
FDA, “Real-Time Oncology Review” https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review Last accessed 26 October 2021
EMA, “Accelerated assessment” https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment Last accessed 26 October 2021
Minister of Health, Labour and Welfare l Japan l Strategy of Sakigake https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html Last accessed 26 October 2021
EMA Paediatric Investigation Plans, https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans Last accessed 26 November 2021
EMA, EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15, https://www.ema.europa.eu/en/news/ema-starts-evaluating-use-covid-19-vaccine-comirnaty-young-people-aged-12-15 Last accessed 26 October 2021
EMA, EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17, https://www.ema.europa.eu/en/news/ema-evaluating-use-covid-19-vaccine-moderna-young-people-aged-12-17 Last accessed 26 October 2021
EMA, COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU, https://www.ema.europa.eu/en/news/covid-19-vaccine-spikevax-approved-children-aged-12-17-eu Last accessed 26 October 2021
European Commission, communication from the commission to the european parliament, the european council and the council hera Incubator: Anticipating together the threat of COVID-19 variants, https://ec.europa.eu/info/sites/default/files/communication-hera-incubator-anticipating-threat-covid-19-variants_en.pdf Last accessed 26 October 2021
European Commission, “Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants” https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1088 Last accessed 25 November 2021
European Commission, communication from the commission to the european parliament, the european council and the council hera Incubator: Anticipating together the threat of COVID-19 variants, https://ec.europa.eu/info/sites/default/files/communication-hera-incubator-anticipating-threat-covid-19-variants_en.pdf Last accessed 26 October 2021
European Medicine Agency, Pandemic report and lessons learned Outcome of the European Medicines Agency's activities during the 2009 (H1N1) flu pandemic, https://www.ema.europa.eu/en/documents/report/pandemic-report-lessons-learned-outcome-european-medicines-agencys-activities-during-2009-h1n1-flu_en.pdf Last accessed 26 October 2021
WHO and ICMRA joint Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during Covid-19 pandemic –December 2020 https://www.icmra.info/drupal/sites/default/files/2021-12/Regulatory_Flexibilities_during_COVID-19_Report.pdf Last accessed 2 December 2021
Science Direct, Esteban Herrero-Martinez, Nasir Hussain, Nadege Le Roux, Judith MacDonald, Mark Mayer, Rodrigo Palacios and Thomas C. Kühler. Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the benefit of patients and public health – An EFPIA view. In press in Clinical Therapeutics. https://www.sciencedirect.com/science/article/pii/S0149291821004562 Last accessed 1 December 2021
Conclusion
IFPMA EFPIA PhRMA BIO ABPI Statement, Global COVID-19 Summit: Ending the Pandemic and Building Back Better, https://www.ifpma.org/resource-centre/ifpma-efpia-phrma-bio-abpi-statement-global-covid-19-summit-ending-the-pandemic-and-building-back-better/ Last accessed 26 November 2021
Disclosure
Acknowledgments
Disclaimer
References
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