NICE u-turn on Opdivo for skin cancer recurrence

UK – NICE u-turn on Opdivo for skin cancer recurrence

The Institute rejected use of the drug in this setting earlier this year on grounds that it was not cost-effective enough, but has now...
Advice for Management of Clinical trials in relation to Coronavirus

Europe – UK and Russia sign MoU on Regulatory Cooperation on Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MoU) with its Russian counterpart; the State Institute of Drugs...
What Happens to SPCs and Patents After the Brexit Transition Period

UK – What Happens to SPCs and Patents After the Brexit Transition Period

Authorisations from the European Medicines Agency Authorisations from the European Medicines Agency will be converted into equivalent UK authorisations on 1 January 2021. Guidance on...

Europe – ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities...

Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests...
European Commission publishes titanium dioxide classification

Europe – European Commission tightens requirements for duplicate MAAs

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three...

Europe – COVID-19 vaccine safety update COVID-19 VACCINE JANSSEN

The safety of COVID-19 Vaccine Janssen is continuously monitored and safety updates are regularly provided to the public. This document outlines the outcomes from...

Europe – COMP meeting report on the review of applications for orphan designation: January...

The COMP adopted 12 positive opinions recommending the following medicines for designation as orphan medicinal products to the European Commission: 1. Opinions adopted at the...

Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature...

EMA has recommended granting a marketing authorisation in the European Union (EU) under exceptional circumstances for Zokinvy (lonafarnib), a treatment for patients with a genetically confirmed diagnosis of...
Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group

Europe – Reflection paper on the qualification of non-genotoxic impurities

The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines state that qualification is the process of acquiring and...
Clinical Trial Regulation : Update

Europe – ICH M10 on bioanalytical method validation

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the...

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