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: May 7, 2021

    Coronavirus (COVID-19) Update: May 7, 2021

    Coronavirus (COVID-19) Update: May 7, 2021

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  • Visit Parexel's COVID 19 Clearinghouse

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  • Disinfect & Shield - 613716 - 05/06/2021

    Disinfect & Shield - 613716 - 05/06/2021

    Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021, PRAC, 07/05/2021

    This month EMA’s safety committee (PRAC) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine...

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  • EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19, CHMP, 07/05/2021

    EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal...

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  • Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

    Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

    FDA issued a new report outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations.

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  • Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

    Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

    FDA issued a new report outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations.

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  • Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant

    New England Journal of Medicine, Ahead of Print.

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  • Audio Interview: India’s Covid-19 Crisis

    New England Journal of Medicine, Volume 384, Issue 18, May 2021.

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  • Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants

    New England Journal of Medicine, Ahead of Print.

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  • Missing the Point — How Primary Care Can Overcome Covid-19 Vaccine “Hesitancy”

    New England Journal of Medicine, Ahead of Print.

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  • Coronavirus (COVID-19) Update: May 4, 2021

    Coronavirus (COVID-19) Update: May 4, 2021

    Coronavirus (COVID-19) Update: May 4, 2021

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  • Coronavirus (COVID-19) Update: May 4, 2021

    Coronavirus (COVID-19) Update: May 4, 2021

    Coronavirus (COVID-19) Update: May 4, 2021

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  • EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, CHMP, 04/05/2021

    EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co.,...

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  • EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 , CHMP, 03/05/2021

    EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15.Comirnaty is a...

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  • Coronavirus (COVID-19) Update: April 30, 2021

    Coronavirus (COVID-19) Update: April 30, 2021

    Coronavirus (COVID-19) Update: April 30, 2021

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  • EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen, CHMP, 29/04/2021

    EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10...

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  • Beyond the First Dose — Covid-19 Vaccine Follow-through and Continued Protective Measures

    New England Journal of Medicine, Ahead of Print.

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