Esmya: new measures to minimise risk of rare but serious liver injury

Europe – Esmya: new measures to minimise risk of rare but serious liver injury

EMA concludes review of medicine for uterine fibroids On 31 May 2018, the European Medicines Agency (EMA) recommended that several measures be put in place...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – NICE OKs NHS funding for Gilead’s CAR T-cell therapy

The National Institute for Health and Care Excellence says the treatment can be funded via the Cancer Drugs Fund for adults with relapsed or...
Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.

Europe – Solution concentrée d’infliximab : première monographie d’anticorps monoclonal dans la Ph. Eur.

En adoptant la monographie « Infliximab (solution concentrée d’) (2928) » lors de sa 159e session (Strasbourg, 21-22 novembre 2017), la Commission européenne de...
Biological medicine quality to receive major boost

UK – How to make submissions to the MHRA if the UK leaves the...

The Agency is making preparations to ensure that in the event we leave the EU with no deal, you can continue to submit regulatory...
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 – International regulators provide guiding principles for COVID-19 clinical trials

EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around...
Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group

Europe – Brexit-related guidance for companies

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of...
DEKRA accredited under the MDR

Europe – European Commission Revises Q&A on Safety Features for Medicinal Products

The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal...
Clinical Trial Regulation : Update

Europe – First oral add-on treatment to insulin for treatment of certain patients with...

EMA’s human medicines committee (CHMP) has recommended for the first time an adjunct treatment to insulin in the form of a tablet for certain...
EMA facilitates early engagement with medicine developers to combat antimicrobial resistance

Europe – EMA facilitates early engagement with medicine developers to combat antimicrobial resistance

As of today, EMA is opening up the early dialogue available through its Innovation Task Force (ITF) to all medicine developers who work on therapeutic approaches for...

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