Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

Europe – Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin...

The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering...
Regulatory Science to 2025

Europe – Regulatory Science to 2025

The European Medicines Agency's (EMA) draft 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next...
Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods

Europe – Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation...

Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be...
Evaluation of anticancer medicinal products in man :Concept paper on the revision of the guideline

Europe – Evaluation of anticancer medicinal products in man : Concept paper on the...

This concept paper introduces revision 6 proposing amendments and add-ons to the last version of the guideline on the evaluation of anticancer medicinal products...
Revised guideline aims to strengthen global approach to development of new antibacterial medicines

Europe – Revised guideline aims to strengthen global approach to development of new antibacterial...

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation....
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...
Produits biothérapeutiques vivants (PBV) : exigences de qualité sans précédent fixées par la Commission

Europe – Produits biothérapeutiques vivants (PBV) : exigences de qualité sans précédent fixées par...

Lors de sa 160e session, la Commission européenne de Pharmacopée a franchi une étape importante dans l’établissement d’exigences de qualité pour les produits biothérapeutiques vivants...
Good pharmacovigilance practice (GPvP)

UK – Good pharmacovigilance practice

Overview Good Pharmacovigilance Practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the EU. MHRA inspects marketing authorisation...
NICE says Novartis' migraine drug Aimovig too costly for NHS

UK – NICE says Novartis’ migraine drug Aimovig too costly for NHS

The drug was approved for use in Europe in July last year as the region's first treatment specifically designed to prevent migraine. The monoclonal antibody...
Guidance for marketing authorisation transfer - National requirements

Europe – Guidance for marketing authorisation transfer – National requirements

Guidance for marketing authorisation transfer - National requirements updated December 2018

NOS PROCHAINES FORMATIONS