UK – NICE publishes guidance on Astellas’ Xospata

The endorsement remains contingent on the confidential commercial agreement agreed with the company, and does not include its use as a maintenance therapy after...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Publication de Pharmeuropa 32.4

Tous les nouveaux textes et les textes révisés pour des raisons techniques sont publiés dans Pharmeuropa pour enquête publique. La date limite de réception des commentaires...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – La Pharmacopée Européenne met à jour le contrôle de la contamination particulaire...

En novembre 2019, lors de sa 165e session, la Commission européenne de Pharmacopée a adopté deux chapitres généraux relatifs au contrôle de la contamination particulaire dans les...

Europe – EU vows to hold COVID vaccine firms liable for side effects

Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Practical guidance for procedures related to Brexit for medicinal products for human...

This practical guidance complements Notice to stakeholders – withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary...
NICE pushes Doptelet for pre-surgery liver disease treatment

UK – Final NICE guidance issued for Akcea’s Tegsedi

The Highly Specialised Technologies (HST) Guidance is for the treatment of stage I or II polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). It...
Biological medicine quality to receive major boost

UK – Brexit No-deal: MHRA Looks to Ease Grandfathering of Centrally Authorized Products

In a recent letter, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) requested firms with centrally authorized products (CAPs) take more preparatory actions...

Europe – EMA weighs COVID-19 data transparency, not ready to resume full clinical data...

In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA)...
NICE refuses Keytruda, Inlyta cancer combo

UK – AZ to appeal NICE rejection for lung cancer drug

The committee didn’t OK the drug as the cost effectiveness estimates were above what NICE normally considers to be an acceptable use of NHS...
Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group

Europe – EudraVigilance Release Notes v.1.20

This document lists and briefly describes the following areas for the releases of the EudraVigilance system. This includes the EudraVigilance messaging system, the EVWEB...

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