NICE rejects NHS funding for Tegsedi, Onpattro

Europe – NICE no for BMS’ multiple sclerosis drug Zeposia

In an appraisal consultation document, NICE said that although there is evidence that Zeposia can reduce the number relapses and brain lesions compared to...
EMA Management Board – highlights of March 2020 meeting

Europe – Amid pandemic, EMA’s 2020 authorizations ticked upward

Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – COVID-19 and vaccines: Equitable access to vaccination must be ensured

How can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – EC asks EMA to accelerate approval of vaccine facilities

The European Commission has called on the European Medicines Agency (EMA) to “speed up the approval process for new production facilities” to increase access...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Le nouveau Guide technique de la Pharmacopée Européenne pour l’élaboration des monographies...

Le nouveau Guide technique pour l’élaboration des monographies de médicaments contenant des substances actives chimiquement définies (2020) a été approuvé par la Commission européenne de Pharmacopée...

Europe – EMA : Human medicines – highlights of 2020

EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended...

UK – NICE publishes final guidance backing Jyseleca for rheumatoid arthritis

The FAD means that the daily oral pill will now be available on the NHS in England for the treatment of eligible adults patients...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Reorganisation of the Romanian blood system – NEW Deadline for tendering: Consultants...

NEW Deadline: 5 February 2021, midnight (CET) The EDQM/Council of Europe will implement the “Reorganisation of the Romanian Blood System” project. The project aims to...

Ireland – Time-limited conditional exemptions to facilitate supply of medicines to the Irish market

As outlined on the HPRA website on 1 January 2021, the European Commission has published a Notice on ‘Application of the Union’s pharmaceutical acquis in markets...
EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list

Europe – EMA : Reporting suspected side effects of medicines in patients with COVID-19

Report suspected side effects of medicines taken while you have COVID-19 to your doctor, nurse, pharmacist, directly to your national medicines authority or to...

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