MHRA Offers Advice on use of Brand Names to Prescribe Drugs

UK – MHRA Offers Advice on use of Brand Names to Prescribe Drugs

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is...
Levothyrox et médicaments à base de lévothyroxine : Rapport final

France – Levothyrox et médicaments à base de lévothyroxine : Rapport final

Les résultats ne fournissent pas d’argument en faveur d’une toxicité propre de la nouvelle formule du Levothyrox. Ils reflètent plutôt les difficultés rencontrées par ...
Point de situation sur la disponibilité des corticoïdes en France - Point d'Information

France – Point de situation sur la disponibilité des corticoïdes en France – Point...

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) est mobilisée depuis plusieurs mois afin d’assurer la continuité de l’accès aux...
Update on the EDQM review of CEP applications for sartans and next steps (June 2019)

Europe – General chapter 5.8 Pharmacopoeial harmonisation: new concept for the Ph. Eur. 10th...

The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of the general chapter on Pharmacopoeial harmonisation (5.8) which will be published in the upcoming 10th...
Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs

The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

Canada – Statement on the Investigational Use of Marketed Drugs in Clinical Trials

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada. It will serve as...
China to tighten rules on foreigners using genetic material

China – China to tighten rules on foreigners using genetic material

China said on Monday it will tighten regulations on human genetic material, putting checks on the passing of it abroad and insisting that any...
Brexit sans accord: la Commission européenne fait le point sur les préparatifs avant le Conseil européen (article 50) de juin

Europe – Brexit sans accord: la Commission européenne fait le point sur les préparatifs...

Dans la perspective du Conseil européen (article 50) de juin, la Commission européenne a aujourd'hui dressé le bilan – dans sa cinquième communication relative à la...
EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019.

Europe – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreementbetween the European Union (EU) and the United States Food and Drug Administration...
Therapeutic goods advertising: Ensuring 'natural' claims are not misleading

Australia – Therapeutic goods advertising: Ensuring ‘natural’ claims are not misleading

Introduction The use of the term 'natural' (and related terms such as 'naturally derived', 'sourced from nature', 'all natural') in therapeutic goods advertising is regulated...

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