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.
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View NowCOVID-19 Health Authority updates
A summary of global health authorities updates in response to COVID-19.
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Learn MoreThe 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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Learn MoreAgainst 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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Learn MoreCoronavirus (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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Learn MoreDisinfect & 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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Learn MoreCoronavirus (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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Learn MoreCoronavirus (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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Learn MoreCoronavirus (COVID-19) Update: May 4, 2021
Coronavirus (COVID-19) Update: May 4, 2021
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Learn MoreCoronavirus (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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Learn MoreCoronavirus (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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