| ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness |
ICMRA |
2021-01-19 |
English |
Global |
View |
| FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic - Update 04-Dec-2020 |
FDA |
2020-12-04 |
English |
USA |
View |
| Considerations for Clinical Trials During the COVID-19 Outbreak |
MPA |
2020-11-23 |
English |
Sweden |
View |
| France (ANSM) Ongoing clinical trials in relation to COVID 19 |
ANSM |
2020-11-17 |
French |
France |
View |
| Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines |
EMA |
2020-11-13 |
English |
European Union |
View |
| Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19 |
MHRA |
2020-11-11 |
English |
United Kingdom |
View |
| Joint Guidance of Swissmedic and swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland During the COVID-19 Pandemic v2.3 |
Swissmedic |
2020-11-04 |
English |
Switzerland |
View |
| NIHR - Guidance for a 'second wave’ of COVID-19 activity |
UK NIHR |
2020-10-12 |
English |
United Kingdom |
View |
| Denmark (DKMA) advice for Clinical trials In relation to COVID 19 |
DKMA |
2020-10-07 |
English |
Denmark |
View |
| Repository of Information from the CCMO for Clinical Trials during the COVID19 Pandemic |
CCMO |
2020-09-30 |
Dutch |
The Netherlands |
View |
| Repository of Information from the CCMO for Clinical Trials during the COVID19 Pandemic |
CCMO |
2020-09-30 |
English |
The Netherlands |
View |
| Estonia (Ravimiamet) advice for Clinical trials In relation to COVID 19 (Updated 29/09/2020) |
Ravimiamet |
2020-09-29 |
English |
Estonia |
View |
| Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsor |
Health Canada |
2020-09-29 |
English |
Canada |
View |
| Clinical trials with trial participants can be gradually (re)started in The Netherlands |
Dutch Ministry of Health |
2020-08-26 |
English |
The Netherlands |
View |
| Conditions to (re)start Clinical Trials in The Netherlands |
Dutch Ministry of Health |
2020-08-25 |
Dutch |
The Netherlands |
View |
| COVID19: Impact on Clinical Trials Conducting under the law of Scientific Research Involving Humans |
Dutch Ministry of Health |
2020-08-25 |
Dutch |
The Netherlands |
View |
| Guidance on the Conduct of Clinical Trials in Relation to the COVID-19 Situation |
HSA |
2020-07-29 |
English |
Singapore |
View |
| Guidelines to Sponsors, Sites, and Researchers re Clinical Research and Bioequivalence Studies |
ANVISA |
2020-07-28 |
Portuguese |
Brazil |
View |
| Exceptional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency |
AEMPS |
2020-07-01 |
Spanish |
Spain |
View |
| Guidelines for Clinical Trials during COVID-19 Emergency |
INS |
2020-06-26 |
Spanish |
Peru |
View |
| Clinical trials with trial participants can be gradually (re)started in The Netherlands |
Dutch Ministry of Health |
2020-06-25 |
Dutch |
The Netherlands |
View |
| Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency |
FDA |
2020-06-17 |
English |
USA |
View |
| Conditions for (re)starting studies in Clinical Research Units |
CCMO |
2020-06-09 |
English |
The Netherlands |
View |
| Ireland (HPRA) advice for Clinical trials In relation to COVID 19 |
HPRA |
2020-05-29 |
English |
Ireland |
View |
| Clinical Trials During the COVID-19 Pandemic |
BfArM |
2020-05-27 |
German |
Germany |
View |
| Clinical Trials During the COVID-19 Pandemic |
BfArM |
2020-05-27 |
English |
Germany |
View |
| Netherlands (CCMO) advice for Clinical trials In relation to COVID 19 |
CCMO |
2020-05-26 |
English |
The Netherlands |
View |
| Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic |
EMA, HMA, EC |
2020-05-26 |
English |
European Union |
View |
| Simplified procedures for studies and compassionate therapeutic use programs for the emergency from COVID-19 |
AIFA |
2020-05-22 |
Italian |
Italy |
View |
| Framework for Restarting NIHR Research Activities which have been Paused due to COVID-19 |
UK NIHR |
2020-05-21 |
English |
United Kingdom |
View |
| Clinical Trial Sponsor Guidelines for Emergency Management |
ALIMS |
2020-05-14 |
Serbian (Cyrillic) |
Serbia |
View |
| Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic |
arXiv (Cornell University) |
2020-05-14 |
English |
|
View |
| Good clinical practice of medicinal products during the COVID-19 pandemic |
GCPpl, INFARMA, PolCRO |
2020-05-13 |
English |
Poland |
View |
| Good clinical practice of medicinal products during the COVID-19 pandemic |
GCPpl, INFARMA, PolCRO |
2020-05-13 |
Polish |
Poland |
View |
| Special additional recommendations for Greece regarding European Instructions for management of Clinical Trials during COVID-19 pandemic |
EOF |
2020-05-13 |
Greek |
Greece |
View |
| Exceptional measures in the context of Clinical Trials during the period of risk to public health (COVID-19) |
INFARMED |
2020-05-11 |
Portuguese |
Portugal |
View |
| Guidelines for Clinical Trials in Slovakia During the COVID-19 Exceptional Situation |
ŠÚKL |
2020-05-06 |
Slovakian |
Slovakia |
View |
| National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic |
ICMR |
2020-05-06 |
English |
India |
View |
| OGYÉI (Hungary) - Information on the Continuity of Clinical Trials Under COVID-19 (coronavirus) |
OGYÉI (Hungary) |
2020-05-05 |
Hungarian |
Hungary |
View |
| Guidance on the Management of Clinical Investigations during the COVID-19 (Coronavirus) Pandemic |
FAMHP |
2020-04-30 |
English |
Belgium |
View |
| Belgium (FAMHP) Guidance for Clinical trials In relation to COVID 19 |
FAMHP |
2020-04-29 |
English |
Belgium |
View |
| Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic - v3.0 28-Apr-2020 |
European Commission |
2020-04-28 |
English |
European Union |
View |
| Managing clinical trials during coronavirus (COVID-19) |
MHRA |
2020-04-22 |
English |
United Kingdom |
View |
| CDISC Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic |
CDISC |
2020-04-21 |
English |
Global |
View |
| Guidance to Sponsors and Investigators for Conduct of Clinical Trials during the COVID-19 Pandemic in Kenya |
PPB |
2020-04-20 |
English |
Kenya |
View |
| Open-access Global COVID-19 Clinical Trial Tracker |
Cytel |
2020-04-11 |
English |
Global |
View |
| COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors |
TGA, NHMRC, and CTPRG |
2020-04-09 |
English |
Australia |
View |
| Guidance for Research Impacted by COVID-19 |
HHS OHRP |
2020-04-08 |
English |
U.S.A. |
View |
| Spain (AEMPS) advices for Clinical trials In relation to COVID 19 |
AEMPS |
2020-04-07 |
Spanish |
Spain |
View |
| Management of clinical studies in Italy during the COVID-19 emergency |
AIFA |
2020-04-07 |
Italian |
Italy |
View |
| Statement of Polish Society of Ethics Committee Members and Employees on ethics committees activities for clinical trials in relation to COVID-19 |
SCiPKBwP |
2020-04-06 |
Polish |
Poland |
View |
| EMA recommendations on compassionate use of remdesivir for COVID-19 |
EMA |
2020-04-03 |
English |
European Union |
View |
| Notification on MedDRA terms for coronavirus |
MedDRA |
2020-04-01 |
English |
Global |
View |
| EU Link to National Guidance on CT Management During the COVID-19 Pandemic |
EU HMA CTFG |
2020-03-31 |
English |
European Union |
View |
| Communique regarding prioritization of clinical trials for COVID-19 |
OGITT/INS |
2020-03-30 |
Spanish |
Peru |
View |
| European (EMA) advices for Clinical trials In relation to COVID 19 |
EMA |
2020-03-27 |
English |
Europe |
View |
| Romania (AMNDMR) advices for Clinical trials In relation to COVID 19 |
AMNDMR |
2020-03-27 |
Romanian |
Romania |
View |
| EMA HMA EC Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic |
EMA, HMA, EC |
2020-03-27 |
English |
Europe |
View |
| Netherlands (CCMO) Accelerated Procedure fast track Assessment of Coronavirus Research Files |
CCMO |
2020-03-27 |
English |
The Netherlands |
View |
| Italy (AIFA) Repository of guidances for Clinical Trials in relation to COVID 19 |
AIFA |
2020-03-27 |
Italian |
Italy |
View |
| Denmark (DKMA) puts Site Inspection and Control Tasks on hold - COVID 19 |
DKMA |
2020-03-26 |
English |
Denmark |
View |
| Supplementary Recommendations to the Document "European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic" - v1.0 26-Mar-2020 |
BfArM |
2020-03-26 |
English |
Germany |
View |
| Supplementary Recommendations to the Document "European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic" - v1.0 26-Mar-2020 |
BfArM |
2020-03-26 |
German |
Germany |
View |
| Communique regarding sponsor considerations for ongoing clinical trials during COVID-19 outbreak |
OGITT/INS |
2020-03-26 |
Spanish |
Peru |
View |
| Policy on Conduct of Clinical Trials of Health Products During the Current COVID-19 Pandemic |
SAHPRA |
2020-03-25 |
English |
South Africa |
View |
| COVID-19 Clinical Trials Information |
NAMMDR |
2020-03-25 |
English |
Romania |
View |
| Hungary (OGYÉI) advice for Clinical trials In relation to COVID 19 |
OGYÉI |
2020-03-24 |
Hungarian |
Hungary |
View |
| United Kingdom (MHRA) Guidance on Coronavirus - Update 24/03/2020 |
MHRA |
2020-03-24 |
English |
United Kingdom |
View |
| Recommendations to the Sponsors for managing of Clinical Trials during the COVID-19 pandemic and the declared State of emergency in the Republic of Bulgaria |
BDA |
2020-03-24 |
English |
Bulgaria |
View |
| FDA guidance on Clinical Trials in relation to Coronavirus |
FDA |
2020-03-20 |
English |
USA |
View |
| FDA Inspections outside the US |
FDA |
2020-03-20 |
English |
USA |
View |
| France (ANSM) Ongoing clinical trials in relation to COVID 19 |
ANSM |
2020-03-20 |
English |
France |
View |
| U.K. NHS HRA COVID-19: Guidance for Sponsors, Sites and Researchers (v2.1 20 March 2020) |
U.K. NHS Health Research Authority |
2020-03-20 |
English |
United Kingdom |
View |
| Guidance to Sponsors on How to Manage Clinical Trials During the COVID-19 Pandemic |
MoH |
2020-03-20 |
English |
Cyprus |
View |
| Expedited Evaluation Strategy of Drug Research Protocols for COVID-19 |
INVIMA |
2020-03-20 |
Spanish |
Colombia |
View |
| Measures to be Taken in Clinical Research Due to COVID-19 Pandemic - FAQs |
TITCK |
2020-03-20 |
Turkish |
Turkey |
View |
| Finland (FIMEA) advice for Clinical trials In relation to COVID 19 |
FIMEA |
2020-03-19 |
English |
Finland |
View |
| Norway (NoMA) advice for Clinical trials In relation to COVID 19 (Updated 19/03/2020) |
NoMA |
2020-03-19 |
English |
Norway |
View |
| Poland (URPL) advice for clinical trials in relation to COVID-19 |
URPL |
2020-03-19 |
Polish |
Poland |
View |
| Processing of Personal Data in the Context of the COVID-19 Outbreak |
EDPB |
2020-03-19 |
English |
European Union |
View |
| Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials |
FDA |
2020-03-18 |
English |
USA |
View |
| Communique regarding clinical trial initiation, maintenance, and conclusion during COVID-19 outbreak |
OGITT/INS |
2020-03-18 |
Spanish |
Peru |
View |
| Austria (BASG) advice for Clinical trials In relation to COVID 19 |
BASG |
2020-03-17 |
English |
Austria |
View |
| Latvia (SAMRL | ZVA) advice for Clinical trials In relation to COVID 19 |
SAMRL (ZVA) |
2020-03-17 |
English |
Latvia |
View |
| Coronavirus clinical research guidelines |
INVIMA |
2020-03-17 |
Spanish |
Colombia |
View |
| Latvia (SAMRL | ZVA) advice for Clinical trials In relation to COVID 19 |
SAMRL (ZVA) |
2020-03-16 |
Latvian |
Latvia |
View |
| Slovakia (ŠÚKL) advice for Clinical trials In relation to COVID 19 |
ŠÚKL |
2020-03-16 |
Slovakian |
Slovakia |
View |
| Slovenia (JAZMP) advice for Clinical trials In relation to COVID 19 |
JAZMP |
2020-03-13 |
Slovenian |
Slovenia |
View |
| ACRO Considerations to Support Clinical Trial Monitoring Oversight During COVID 19 |
ACRO |
2020-03-13 |
English |
USA |
View |
| Italy (AIFA) advice for Clinical trials In relation to COVID 19 |
AIFA |
2020-03-12 |
English |
Italy |
View |
| United Kingdom (MHRA) Advice for Management of Clinical trials in relation to COVID 19 |
MHRA |
2020-03-12 |
English |
United Kingdom |
View |