ECRIN - European Clinical Research Infrastructure Network

Regulatory – ethical considerations for ongoing trials during Pandemic

 

GUIDANCE/WEBPAGE DOCUMENT AGENCY COUNTRY
Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 3 (28/04/2020) EMA
European Union
Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic Date: 25.3.2020 Version: v1 Federal Agency for Medicines and Health Products
Belgium
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 Opinion SÚKL
Czech Republic
Covid 19 - Ongoing clinical trials 8 April 2020 ANSM
France
Supplementary recommendations to the document European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic v1 26 March 2020
v2.3 27 May 2020
Bundesinstitut fuer Arzneimittel und Medizinprodukte
Germany
Information on the continuity of clinical trials under COVID-19 (reference to EMA document) (coronavirus) - 25.03.2020 v1 25.03.2020  
Hungary
Guidance on the Management of Clinical Trials during COVID-19 This guidance was updated on 2 April 2020 (version 5.0) HRPA
Ireland
Clinical trials’ management in Italy during the COVID-19 (coronavirus disease 19) emergency Clinical trials’ management in Italy during the COVID-19 (coronavirus disease 19) emergency AIFA
Italy
Management of Clinical Trials in relation to covid-19 Up-dated 19.03.2020 The Norwegian Medicines Agency NoMA
Norway
Communication of Director General of 17 March 2020 on the activities of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in connection with the SARS-CoV-2 coronavirus pandemic Information in English posted Fri, 20/03/2020 - 13:06 REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Poland
CEIC information regarding clinical trials or intervention studies with MD in view of the current conjecture of Covid-19 Version updated on 31-Mar-2020 CEIC
Portugal
ŠÚKL GUIDANCE FOR THE CLINICAL TRIALS IN SLOVAKIA DURING THE EXCEPTIONAL COVID-19 SITUATION Version 1 (2.4. 2020) SUKL
Slovakia
Medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas derivados de la emergencia por COVID-19 -- Exceptional measures applicable to clinical trials to manage compliance issues arising from COVID-19 emergency 16 de marzo de 2020 Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Spain
Joint guidance of Swissmedic and swissethics on the conduct of clinical trials during COVID-19 pandemic Version 2.1. 07 April 2020 Swissmedic / Swissethics
Switzerland
Managing clinical trials during coronavirus (COVID-19) 20 March 2020 MHRA
United Kingdom
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic March 2020 Updated on April 2, 2020 FDA
USA
EF-GCP- Repository of publications for Clinical Trials in relation to COVID-19 Links to relevant documents in many countries European Forum of GCP
Global coverage

 Last update on 04-06-2020.

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