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: January 22, 2021
Coronavirus (COVID-19) Update
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Learn MoreCoronavirus (COVID-19) Update: January 22, 2021
Coronavirus (COVID-19) Update
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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...
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Audio Interview: An International Look at Covid-19
New England Journal of Medicine, Volume 384, Issue 3, January 2021.
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Monoclonal Antibodies to Disrupt Progression of Early Covid-19 Infection
New England Journal of Medicine, Volume 384, Issue 3, Page 289-291, January 2021.
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Vaccinating Children against Covid-19 — The Lessons of Measles
New England Journal of Medicine, Ahead of Print.
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Covid-19 Vaccine Injuries — Preventing Inequities in Compensation
New England Journal of Medicine, Ahead of Print.
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Learn MoreCoronavirus (COVID-19) Update: January 19, 2021
Coronavirus (COVID-19) Update
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Learn MoreHand Sanitizers | COVID-19
Help meet the increased demand for safe and effective hand sanitizers during the COVID-19 public health emergency
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Learn MorePolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)
COVID-19
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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...
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Learn MoreCoronavirus (COVID-19) Update: January 15, 2021
Coronavirus (COVID-19) Update
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Learn MoreCoronavirus (COVID-19) Update: January 15, 2021
Coronavirus (COVID-19) Update
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Learn MoreProtecting 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.
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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...
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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...
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Learn MorePandemic Response, Pandemic Preparation
Pandemic Recovery and Preparedness Plan (PREPP) initiative strengthens on-going COVID-19 pandemic response and our resiliency for future public health emergencies.
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