COVID-19

Your central place to rapidly access latest news, translated guidance information, and expert interpretations from our former regulators related to COVID-19. Parexel’s 1000+ consulting experts are closely following agency announcements and new guidances and can help provide deep expertise and experience in the race to bring this outbreak to a close. We’re here to fight this with you.

  • COVID-19 Health Authority updates

    COVID-19 Health Authority updates

    A summary of global health authorities updates in response to COVID-19.

    View Now
  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

    Learn More
  • See Parexel's latest COVID-19 expert content

    View all
  • Against All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?

    Against All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?

    Key Takeaways The COVID-19 pandemic has drawn attention to international efforts to promote...

    Learn More
  • Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020

    Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020

    Remarks by Stephen. Hahn, MD, Commissioner of Food and Drugs, The National Academy of Medicine Town Hall on the COVID-19 Vaccine, Dec. 4, 2020

    Learn More
  • Visit Parexel's COVID 19 Clearinghouse

    Visit Now
  • Coronavirus (COVID-19) Update: January 22, 2021

    Coronavirus (COVID-19) Update: January 22, 2021

    Coronavirus (COVID-19) Update

    Learn More
  • Coronavirus (COVID-19) Update: January 22, 2021

    Coronavirus (COVID-19) Update: January 22, 2021

    Coronavirus (COVID-19) Update

    Learn More
  • Extra dose from vials of Comirnaty COVID-19 vaccine, , 08/01/2021

    EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of...

    Learn More
  • Audio Interview: An International Look at Covid-19

    New England Journal of Medicine, Volume 384, Issue 3, January 2021.

    Learn More
  • Monoclonal Antibodies to Disrupt Progression of Early Covid-19 Infection

    New England Journal of Medicine, Volume 384, Issue 3, Page 289-291, January 2021.

    Learn More
  • Vaccinating Children against Covid-19 — The Lessons of Measles

    New England Journal of Medicine, Ahead of Print.

    Learn More
  • Covid-19 Vaccine Injuries — Preventing Inequities in Compensation

    New England Journal of Medicine, Ahead of Print.

    Learn More
  • Coronavirus (COVID-19) Update: January 19, 2021

    Coronavirus (COVID-19) Update: January 19, 2021

    Coronavirus (COVID-19) Update

    Learn More
  • Hand Sanitizers | COVID-19

    Hand Sanitizers | COVID-19

    Help meet the increased demand for safe and effective hand sanitizers during the COVID-19 public health emergency

    Learn More
  • Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency  (COVID-19)

    Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)

    COVID-19

    Learn More
  • Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines, , 19/01/2021

    EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help...

    Learn More
  • Coronavirus (COVID-19) Update: January 15, 2021

    Coronavirus (COVID-19) Update: January 15, 2021

    Coronavirus (COVID-19) Update

    Learn More
  • Coronavirus (COVID-19) Update: January 15, 2021

    Coronavirus (COVID-19) Update: January 15, 2021

    Coronavirus (COVID-19) Update

    Learn More
  • Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency

    Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency

    This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency.

    Learn More
  • Cyberattack on EMA - update 5, , 15/01/2021

    The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...

    Learn More
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021, PRAC, 15/01/2021

    First monthly summary safety report for COVID-19 vaccine ComirnatyStarting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports...

    Learn More
  • loading
    Loading More...