National Guidances for Conducting Clinical Trials During the COVID-19 Pandemic

FDA, EMA and many national drug agencies have issued national recommendations and guidelines for ongoing clinical trials. They are focusing on providing support for patients, sites and investigators during the COVID-19 pandemic. Many of these guidelines suggest avoiding sites visits whenever possible as well as advice for remote monitoring visits.

USA, FDA

Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

Europe, EMA

Coronavirus disease (COVID-19) updates and regulations

Belgium, Federal Agency for Medicines and Health Products

Directive on direct drug delivery to patients in clinical trials

Germany, Federal Institute for Drugs and Medical Devices

Approval procedure (COVID-19 clinical trials)

Ireland, Irish Medicines Board

COVID-19 and the Regulation of Health Products – Latest Information including Guidance on Regulatory Submissions during COVID-19

Italy,National Institute of Health

Ethical Framework for Health Care Institutions Responding to Novel Coronavirus SARS-CoV-2 (COVID-19)

UK, Medicines and Healthcare Regulatory Agency (MHRA)

MHRA update on novel coronavirus (COVID-19)

Bulgaria, Bulgarian Drug Agency

Guidance for sponsors conducing clinical trials (related to COVID-19 pandemic)

Netherlands, Medicines Evaluation Board

EMA plan for emerging health threats

Czech Republic, State Institute For Drug Control

Supplementary opinion of the SÚKL Clinical Trials Department on ongoing clinical trials in connection with the current epidemiological situation with COVID-19 of 16 March 2020, updated 18 March 2020

Slovakia, State Institute for Drug Control

Emergency Measures For Clinical Trials Due to Covid-19

Hungary, National Institute of Pharmacy

Information on the continuity of clinical trials under COVID-19 (coronavirus) – 16/03/2020

Romania, National Medicines Agency

In the attention of companies conducting clinical studies in Romania

Lithuania, State Medicines Control Agency

Concerning the assurance of conducting clinical trials during the COVID-19 pandemic

Estonia, State Agency of Medicines

Clinical Trial Guide for the COVID-19 pandemic

Global, Real-time Tracker

Latest Regulations, Guidance and Notices of Authorithies