MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

UK – MHRA joins international partnerships to set global standards for medicines and medical...

The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...

Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine

EMA has started a rolling review for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2,...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022

Update on review of cases of heavy menstrual bleeding with mRNA COVID-19 vaccines The PRAC is continuing its assessment of cases of heavy menstrual bleeding (heavy periods)...

Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines

EMA’s safety committee (PRAC) has recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines. The recommendation follows a review which found that measures to restrict...

Europe – EMA : Complex clinical trials – Questions and answers

This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT...

Europe – EMA publishes annual report 2021

EMA’s annual report 2021 published today provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union...
NICE ‘OK’ for Lynparza

UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks...

Vazkepa is a new active substance, made up of a highly purified omega-3 fatty acid and is the first in this class to be...

Europe – EMA adopts first list of critical medicines for COVID-19

On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of  critical medicines for the COVID-19 public health emergency . The medicines included in the...

Europe – EU regulators offer new guidance on complex clinical trials

European regulators published a question and answer document that they hope will give more clarity on how complex clinical trials (CCT) should be conducted. The document...

UK – NICE approves Merck’s Keytruda for adult patients with rare triple negative breast...

Merck & Co – known as MSD outside the US and Canada – has received a recommendation from The National Institute for Health and...

NOS PROCHAINES FORMATIONS