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 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
| 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) | 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 |
| AIFA |
Italy |
| 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
| 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
| Swissmedic / Swissethics |
Switzerland | |
| Managing clinical trials during coronavirus (COVID-19) | 16 November 2021 | MHRA |
United Kingdom
|
| 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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