Advice for Management of Clinical trials in relation to Coronavirus

UK – Updated guidance on pharmacovigilance procedures

This document outlines the submission requirements for pharmacovigilance data from 1 January 2021. The MHRA will retain responsibility for Pharmacovigilance across the UK from 1 January 2021....

Europe – PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

A review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA: Post-transition guidance on licensing medicines

In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines...

UK – Janssen disappointed with second NICE no for Spravato

Following a second appraisal consultation, the Institute is not recommending use of the spray, in combination with a selective serotonin reuptake inhibitor (SSRI) or...

Europe – EMA finalizes pediatric trial preparedness framework

The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase...
Brexit and Chemicals Regulation: UK Government Sets Out Plans for a UK-Reach in The Event of a Hard-Brexit

UK – MHRA posts suite of post-transition guidances

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical...

Europe – EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients with COVID-19. The application, from Taw Pharma,...

UK – NICE green light for immunotherapy Bavencio

Current NHS treatment for untreated advanced renal cell carcinoma (RCC) includes sunitinib, pazopanib, tivozanib or cabozantinib. NICE concluded that clinical trial evidence shows that, for...

Europe – ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential...

This guideline concerns the clinical evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses the electrocardiograms methodology, gender, positive control, study design,...

UK – Kidney cancer charity slams NICE rejection of Keytruda/Inlyta

The anti-PD-1 therapy combo was approved in Europe in September 2019 based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that...

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