Fast track procedure for COVID 19 clinical trials
Most of the European countries have put in place accelerated procedures (“Fast track” procedure) for the evaluation and authorization of clinical trials related to the management of the pandemic COVID-19. In many countries the regulatory authorities have issued official guidelines for the accelerated procedure. Some of them cover also the ethical review process by the Ethics committee. In case such guidelines are not available/not being proposed, the authorities made a sort of formal statement that they consider the clinical trials on Covid-19 as a top priority. We have collected information from 16 Countries:
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Belgium |
Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic), Federal Agency for Medicines and Health Products Eurostation, 25/03/2020.
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Czech Republic |
No Fast track procedure publically available
Statement from SUKL: they prioritize all requests regarding COVID-19 (approximately 30 days)
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Denmark |
No Fast track procedure publically available
Statement from Danish Medicines agency: they prioritize all requests regarding COVID-19
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France |
Application for an initial authorization for COVID-19 related clinical trial, ANSM, First published 03/20/2020, last update 11/02/2022
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Germany |
No Fast track procedure publically available
Statement from The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM): they prioritize all requests regarding COVID-19
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Italy |
Notice: Clinical trials’ management in Italy during the COVID-19 (coronavirus disease 19) emergency, AIFA, published on 12/03/2020, last update: Version 2 of 7/04/2020
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Ireland |
Ireland’s Health Products Regulatory Authority (HPRA), Department of Health, National Office for Research Ethics Committees and Health Research Declaration Committee have agreed on an expedited review process for human trials related to COVID-19. A dedicated COVID-19 national research ethics committee (NREC-COV19) has been established.
Guidance on the Management of Clinical Trials during COVID-19, HPRA, updated on 02/04/2020 (version 5.0) COVID-19 Related Human Research – Expedited Regulatory and Ethical Review
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Norway |
Management of Clinical Trials in relation to covid-19, Norwegian Medicines Agency (NoMA), published 16/03/2020, updated 19/03/2020
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Poland |
No Fast track procedure publically available
Statement from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and other authorities: they prioritize all requests regarding COVID-19
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Portugal |
COVID-19: Exceptional measures for conduct clincal trial during the COVID 19 (Coronavirus) pandemic, INFARMED, version 2 15/04/2020
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Slovakia |
USMERNENIE ŠÚKL KU KLINICKÝM SKÚŠANIAM NA SLOVENSKU POČAS MIMORIADNEJ SITUÁCIE COVID-19, State Institute for Drug Control (SIDC), version 1 02/04/2020
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Spain |
No Fast track procedure publically available
Statement from the AEMPS : they prioritize all requests regarding COVID-19
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Switzerland |
Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic, Swissethics/Swissmedic, version 2.1, 07/04/2020
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United Kingdom |
Clinical trials applications for Coronavirus (COVID-19), MHRA, 19/03/2020
Related topics
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European Network of Research Ethics Committees |
Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic: “RECs should give clear priority to the assessment of submitted studies that are linked to the prevention or treatment of COVID-19 […]”, EUREC Board, 27/04/2020
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