UK – Government authorises use of dexamethasone for COVID-19

Doctors can now administer the an anti-inflammatory to all UK hospitalised COVID-19 patients requiring oxygen, including those on ventilators. The move follows data from the...
CAT monthly report of application procedures, guidelines and related documents on advanced therapies

Europe – ICH reflection paper on proposed ICH guideline work to advance patient focused...

Patients have direct experience in living with a disease. They have firsthand knowledge of the impact of the disease on their life and on...

Europe – Heterologous primary and booster COVID-19 vaccination

During the spring of 2021, a number of European Union (EU) Member States (MSs) started to apply a strategy of heterologous primary vaccination, with...

Europe – COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir

EMA starts review to support possible national decisions on early use The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on the need...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines

The European Pharmacopoeia (Ph. Eur.) Commission has decided to accept semi-quantitative High-Performance Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which could be...
ECHA to scrutinise all REACH registrations by 2027

Europe – ECHA to scrutinise all REACH registrations by 2027

The Commission will propose an amendment to REACH to raise the current 5 % minimum target for compliance checks to 20 % of registration...

Europe – First treatment for rare liver disease

EMA has recommended granting a marketing authorisation in the European Union for Bylvay (odevixibat) for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged...

International – AZ to seek approval for « long-acting » COVID-19 antibodies

The trial studied more than 5,000 participants who did not have SARS-CoV-2 infection at baseline. During the trial, 25 people developed symptomatic disease including...
Clinical Trial Regulation : Update

Europe – European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance...
Clinical Trial Regulation : Update

Europe – Public-health advice during COVID-19 pandemic

The European Medicines Agency (EMA) is providing impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic,...

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