Currently Browsing: Resources

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

June 9, 2020

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

June 2, 2020

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

June 2, 2020

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

June 2, 2020

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

May 27, 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)

May 27, 2020

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

May 27, 2020

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

May 21, 2020

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

May 8, 2020

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

May 8, 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

April 30, 2020

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

April 30, 2020

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

April 30, 2020

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

April 28, 2020

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

April 23, 2020

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

April 23, 2020

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

April 23, 2020

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

April 23, 2020

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

April 23, 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

April 21, 2020