ECRIN - European Clinical Research Infrastructure Network

Fast track procedure for COVID 19 Clinical trials

Accelerated procedures for the evaluation and authorization of clinical trials related to COVID – 19

National Landscape - last updated May 25, 2020

 

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:

 


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.

Czech Republic
No Fast track procedure publically available

Statement from SUKL: they prioritize all requests regarding COVID-19
Opinion of SÚKL's Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation of 03/042020, added 06/04/2020


Denmark
No Fast track procedure publically available

Statement from Danish Medicines agency: they prioritize all requests regarding COVID-19
Extraordinary measures for clinical trials due to COVID-19, Danish Medicines agency, 13/03/2020, updated 02/04/2020


France
Modalities for the evaluation of clinical trials related to the management of the pandemic COVID, ANSM, first published 03/20/2020, last update 04/08/2020

Related topics
Submission to ANSM for adaptation in ongoing trials when related to COVID-19, ANSM, First published 03/20/2020, last update 04/08/2020


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


Hungary
No Fast track procedure publically available

Statement from OGYEI ( National Institute of Pharmacy and Nutrition) : they prioritize all requests regarding COVID-19


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

Related topics
Circolare sulle procedure semplificate per gli studi gli usi compassionevoli per l'emergenza da COVID-19, AIFA


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


The Netherlands
Accelerated procedure (fast track) review of coronavirus research files, updated 27/03/2020: Procedure fast-track review by CCMO as review committee, Central commitee on research involving human subjects (CCMO), last updated 14/04/2020

Related topics
Additional recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus, CCMO, 14/04/2020

Fast track procedures MRECs
Along with CCMO, a number of accredited MRECs have also set up fast track procedures for the accelerated review of research files on the occurrence and/or treatment of COVID-19


Norway
Management of Clinical Trials in relation to covid-19, Norwegian Medicines Agency (NoMA), published 16/03/2020, updated 19/03/2020

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


Portugal
COVID-19: Exceptional measures for conduct clincal trial during the COVID 19 (Coronavirus) pandemic, INFARMED, version 2 15/04/2020

Related topics
Informação CEIC sobre Ensaios Clínicos ou Estudos de intervenção com DM face à conjetura atual da Covid-19, National ethics committee for clinical research, version 31/03/2020, updated 03/04/2020


Slovakia
USMERNENIE ŠÚKL KU KLINICKÝM SKÚŠANIAM NA SLOVENSKU POČAS MIMORIADNEJ SITUÁCIE COVID-19, State Institute for Drug Control (SIDC), version 1 02/04/2020

Spain
No Fast track procedure publically available

Statement from the AEMPS : they prioritize all requests regarding COVID-19
Medidas adoptadas para facilitar la gestión de las autorizaciones y modificaciones de medicamentos de uso humano considerados esenciales durante la crisis de COVID-19, AEMPS, version 20/04/2020


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

Related topics
Webpage dedicated to Covid-19 at https://www.swissethics.ch/covid-19


United Kingdom
Clinical trials applications for Coronavirus (COVID-19), MHRA, 19/03/2020

Related topics
Managing-clinical-trials-during-coronavirus-covid-19, MHRA, Last updated 22/04/2020


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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