Regulatory – Ethical considerations for ongoing trials during pandemic

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GUIDANCE/WEBPAGE	DOCUMENT	AGENCY	COUNTRY
Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic	Version 5 (10/02/2022)	EMA	Europe
EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines	Rev 3 (16/09/2021)	EMA	Europe
Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials	English version (26/06/2020)	EMA	Europe
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
The Opinion of SUKL´s Department of Clinical Trials of Medicinal Products on ongoing clinical trials and pending clinical trials related to COVID-19 from 22 November 2021 will expire on 23 May 2022. Sponsors should return to the standard regime and should no longer apply for the emergency measures permitted by this statement. With immediate effect, there is no need to comply with: * The recommendation to always ascertain the trial subject's situation in advance by phone, the covid history can be taken during the visit of the subject. * Recommended safety measures in the commencement of clinical trials with healthy volunteers or clinical trials without therapeutic benefit for the enrolled trial subjects. Sponsors may switch to the normal regimen of clinical trials.	Opinion	SÚKL	Czech Republic
Covid 19 - Ongoing clinical trials Post-lock down recommendations	8 April 2020 10 August 2020 9 December 2020	ANSM	France
Supplementary recommendations to the document European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic	v4 (updated 25.02.2021) Clinical Trials during COVID-19 Pandemic	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 7 April 2021 (version 8.0)	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 - V3 17/09/2020	AIFA	Italy
Management of Clinical Trials in relation to covid-19	Updated 19.03.2020	The Norwegian Medicines Agency NoMA	Norway
Good clinical practice of medicinal products during the COVID-19 pandemic	Information in English posted Fri, 11 January 2021	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 INFARMED information regarding clinical trials or intervention studies with MD in view of the current conjecture of Covid-19	Version updated on 31-Mar-2020* Version 3 update on 11/05/2020	CEIC INFRAMED	Portugal
ŠÚKL GUIDANCE FOR THE CLINICAL TRIALS IN SLOVAKIA DURING THE EXCEPTIONAL COVID-19 SITUATION	Version 3 (9.4. 2021)	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	July 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 Website of Swiss Ethics - with other relevant documents	Version 2.4. 17 December 2020 Website of Swissethics	Swissmedic / Swissethics	Switzerland
Managing clinical trials during coronavirus (COVID-19)	16 November 2021	MHRA	United Kingdom
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic	March 2020, updated on January 27, 2021	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

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Last update on 10-02-2022.

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