COVID-19 Resources

Food and Drug Administration: Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

Update #7: June 3, 2020

Original: March 18, 2020

National Medical Product Administration Blogpost: Research well underway into COVID-19 vaccines and drugs, premier says

Original: May 29, 2020

Health Canada Guidance: Applications for drug clinical trials under the Interim Order

Original: May 27, 2020

Central Drugs Standard Control Organisation Guidance: Rapid Response Regulatory Framework for COVID-19 Vaccine development -reg.

Original: May 27, 2020

European Medicines Agency Report: Treatments and vaccines for COVID-19

Original: May 26, 2020

National Institute for Health Research Guidance: A framework for restarting NIHR research activities which have been paused due to COVID-19

Original: May 21, 2020

Food and Drug Administration Guidance: FDA Combatting COVID-19 with Medical Devices

Original: May 20, 2020

Medicines and Healthcare products Regulatory Agency Guidance: MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

Update #4: May 20, 2020

Original: April 1, 2020

Federal Institute for Drugs and Medical Devices Guidance: Supplementary Recommendations to EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (Version 3.0)

Original: May 19, 2020

Food and Drug Administration Guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Original: May 11, 2020

European Medicines Agency Guidance: Guidance for medicine developers and companies on COVID-19

Original: May 7, 2020

Food and Drug Administration Blogpost: Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy

Original: May 4, 2020

European Medicines Agency Guidance: Management of Clinical Trials During the COVID-19 Pandemic

Update #3: April 28, 2020

Original: March 20, 2020

European Commission Press Release: Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU

Original: April 28, 2020

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

Original: April 27, 2020

European Medicines Agency Press Release: International regulators pledge collective support to combat COVID-19 pandemic

Original: April 24, 2020

Medicines and Healthcare products Regulatory Agency Guidance: Managing Clinical Trials During COVID-19

Update #3: April 22, 2020

Original: March 19, 2020

National Medical Products Administration Press Release: China to speed up resuming normal medical services in low-risk regions

Original: April 22, 2020

European Medicines Agency Press Release: Launch of enhanced monitoring system for availability of medicines used for treating COVID-19

Original: April 21, 2020

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

Original: April 21, 2020

Food and Drug Administration Blogpost: The Path Forward: Coronavirus Treatment Acceleration Program

Original: April 20, 2020

Food and Drug Administration Guidance: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

Original: April 16, 2020

European Commission Notice: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use during the COVID-19 Pandemic

Original: April 10, 2020

European Medicines Agency Guidance: Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials

Original: March 25, 2020

Food and Drug Administration Press Release: COVID-19 Update: FDA Continues to Facilitate Development of Treatments

Original: March 19, 2020

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Original: March 18, 2020

National Health Service Guidance: COVID-19 Guidance for Sponsors, Sites and Researchers

Original: March 17, 2020

Department of Health and Social Care Guidance: The Impact of COVID-19 on Research Funded or Supported by NIHR

Original: March 16, 2020

Medicines and Healthcare products Regulatory Agency Blogpost: Advice for Management of Clinical Trials in Relation to Coronavirus

Original: March 12, 2020

Italian Medicines Agency Notice: Clinical Trials’ Management in Italy During the COVID-19 (Coronavirus Disease 19) Emergency

Original: March 12, 2020

COVID-19 Resource Center

ACRO is closely tracking the clinical research industry’s response to COVID-19. You can find guidance from regulators below. We will continue to update this to keep our members informed.

Food and Drug Administration: Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

National Medical Product Administration Blogpost: Research well underway into COVID-19 vaccines and drugs, premier says

Health Canada Guidance: Applications for drug clinical trials under the Interim Order

Central Drugs Standard Control Organisation Guidance: Rapid Response Regulatory Framework for COVID-19 Vaccine development -reg.

European Medicines Agency Report: Treatments and vaccines for COVID-19

National Institute for Health Research Guidance: A framework for restarting NIHR research activities which have been paused due to COVID-19

Food and Drug Administration Guidance: FDA Combatting COVID-19 with Medical Devices

Medicines and Healthcare products Regulatory Agency Guidance: MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

Federal Institute for Drugs and Medical Devices Guidance: Supplementary Recommendations to EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (Version 3.0)

Food and Drug Administration Guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

European Medicines Agency Guidance: Guidance for medicine developers and companies on COVID-19

Food and Drug Administration Blogpost: Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy

European Medicines Agency Guidance: Management of Clinical Trials During the COVID-19 Pandemic

European Commission Press Release: Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

European Medicines Agency Press Release: International regulators pledge collective support to combat COVID-19 pandemic

Medicines and Healthcare products Regulatory Agency Guidance: Managing Clinical Trials During COVID-19

National Medical Products Administration Press Release: China to speed up resuming normal medical services in low-risk regions

European Medicines Agency Press Release: Launch of enhanced monitoring system for availability of medicines used for treating COVID-19

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

Food and Drug Administration Blogpost: The Path Forward: Coronavirus Treatment Acceleration Program

Food and Drug Administration Guidance: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

European Commission Notice: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use during the COVID-19 Pandemic

European Medicines Agency Guidance: Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials

Food and Drug Administration Press Release: COVID-19 Update: FDA Continues to Facilitate Development of Treatments

Food and Drug Administration Press Release: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

National Health Service Guidance: COVID-19 Guidance for Sponsors, Sites and Researchers

Department of Health and Social Care Guidance: The Impact of COVID-19 on Research Funded or Supported by NIHR

Medicines and Healthcare products Regulatory Agency Blogpost: Advice for Management of Clinical Trials in Relation to Coronavirus

Italian Medicines Agency Notice: Clinical Trials’ Management in Italy During the COVID-19 (Coronavirus Disease 19) Emergency