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.

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  • 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...

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  • See Parexel's latest COVID-19 expert content

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  • 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...

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  • Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

    Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

    FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

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  • Visit Parexel's COVID 19 Clearinghouse

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  • Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

    Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

    Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

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  • Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers , CHMP, 25/02/2021

    EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV...

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  • International cooperation to align approaches for regulation of COVID-19 vaccines and medicines, , 25/02/2021

    Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development,...

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  • Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19

    New England Journal of Medicine, Ahead of Print.

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  • Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia

    New England Journal of Medicine, Ahead of Print.

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  • Interleukin-6 Receptor Inhibition in Covid-19 — Cooling the Inflammatory Soup

    New England Journal of Medicine, Ahead of Print.

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  • EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19, , 24/02/2021

    EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is...

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  • BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

    New England Journal of Medicine, Ahead of Print.

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  • Audio Interview: The Real-World Effectiveness of Covid-19 Vaccination

    New England Journal of Medicine, Volume 384, Issue 8, February 2021.

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  • Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

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  • Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021

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  • Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021

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  • EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen, CHMP, 23/02/2021

    EMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require...

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  • Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

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  • Coronavirus (COVID-19) Update: February 19, 2021

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

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

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  • CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

    CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19.

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