EMA Management Board – highlights of March 2020 meeting

International – International regulators discuss available knowledge supporting COVID-19 medicine development

On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by the European Medicines Agency (EMA) under the umbrella...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – EU Regulatory Roundup

MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Products and extemporaneous preparation of paediatric formulations that may be useful in...

During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication...
Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

We are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly develop a package...
NICE pushes Doptelet for pre-surgery liver disease treatment

UK – NICE publishes second set of rapid COVID-19 guidelines

The National Institute for Health and Care Excellence (NICE) has published its second set of rapid guidelines to cover the provision of radiotherapy services...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH: MedDRA existing and supplemental codes for Coronavirus

The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue....

International – Clinical Trials During COVID-19: Updates From FDA, MHRA and TGA

The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The...
Coronavirus delays many FDA foreign inspections

USA – FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately....
Clinical Trial Regulation : Update

Europe – Amended European Union recommendations for the seasonal influenza vaccine composition for the...

The meeting of the Ad hoc Influenza Working Group of the Biologics Working Party (BWP) was convened in order to recommend the virus strains...

Europe – EMA : COVID-19: chloroquine and hydroxychloroquine only to be used in clinical...

Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (COVID-19)....